A Randomized Phase III Trial of Gabapentin Versus Standard of Care for Prevention and Treatment of Mucositis in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation
Phase: PHASE3
Conditions: Malignant Head and Neck Neoplasm, Mucositis, Radiation-Induced Disorder
Sponsor: Vanderbilt-Ingram Cancer Center

 
Protocol Version #: 13 
 
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NCT02480114 
 
VICCHN1541 
 
 
 
 
 
 
A Randomized Phase III Trial of  
Gabapentin versus Standard of Care for  
Prevention and Treatment of Mucositis in  
Locally Advanced Head and Neck Cancer Patients  
Undergoing Primary or Adjuvant Chemoradiation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Derek Smith, DDS, PhD 
Deborah Hawkins, RN, NP 
Mary S. Dietrich, PhD  
Jill Gilbert, MD 
Barbara A Murphy, M.D 
 
 
 
 
 
 
 

 
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Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Animal Studies and Previous Human Studies 
4.0 
Inclusion/Exclusion Criteria 
5.0 
Enrollment/Randomization 
6.0 
Study Procedures 
7.0 
Risks of Investigational Agents/Devices (side effects) 
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
9.0 
Study Withdrawal/Discontinuation 
10.0 
Statistical Considerations 
11.0 
Data Management  
12.0 
Privacy/Confidentiality Issues 
13.0 
Follow-up and Record Retention 
 
Appendices 
Appendix A Demographics 
Appendix B    Vanderbilt Head and Neck Symptoms Survey V2.0  
Appendix C  Pain Diary  
Appendix D Gabapentin Compliance Sheet 
Appendix E Profile of Mood States  
Appendix F  Neurotoxicity Scale Sheet 
Appendix G Quality of Life Sheet 
Appendix H Disease and Treatment Data Form  
Appendix I  Study Calendar  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1.0 Background 
 
1.1 
Head and Neck Cancer 
 
Worldwide, head and neck cancers affect more than 550,000 individuals annually with 
men accounting for up to two-thirds of reported cases [1]. The relative prevalence of head and 
neck cancers can be attributed to the regional variation of risk factors such as tobacco use, 
alcohol consumption and infection from human papillomavirus (HPV) or Epstein-Barr Virus 
(EBV)[1-4]. Within the United States, nearly 4% or about 42,000 cases of of all malignancies 
can be attributed to cancer of the oral cavity and nasopharynx [5]. Treatment for patients with 
and head and neck carcinomas generally include single modal therapy such as chemotherapy or 
radiation therapy or treatment with multimodal therapy such as induction therapy with 
concurrent Chemoradiotherapy[6-11]. Treatment is associated with numerous and often severe 
toxicities.  
 
1.2 
Mucositis 
 
Oral mucositis, ulceration of the oral mucosa, is one of the major and frequent 
complications of radiation and chemotherapy in head and neck cancer patients[12, 13].  A 
combination of dose-related chemoradiation epithelial damage, micro-vascular injury, elevated 
release of cytokines such as TNF-α, and oxidative stress with subsequent generation of reactive 
oxygen species contribute to the development of oral mucositis[12, 14]. Recent data suggests 
that occurrence of severe oral mucositis occurs in up to 66-85% of patient’s [15, 16]. 
Development of mucositis is accompanied with severe pain [13, 17]. Mucositis associated pain 
has a mixed pathogenesis which includes both somatic and neuropathic components. The pain 
symptoms usually begin two to three weeks after the start of chemoradiation therapy and are at 
its worst at the completion of therapy. Development of mucositis in cancer patients has 
significant impacts on health, quality of life, and recovery [14, 17]. Associated pain results in 
dysphagia making it difficult for patients to eat and thus increasing their risk for weight loss and 
volume contraction dehydration throughout therapy as well precipitates the need for parenteral 
nutrition[12, 18]. Furthermore, erosive mucositis puts patients at risk for development of 
secondary infection and sepsis especially in the presence of concurrent neutropenia [14]. Severe 
mucositis may require a dose reduction during therapy, altering the course of Chemoradiotherapy 
originally set forth.  
Current treatment of mucositis includes symptom management with routine oral care, 
mucosal coating agents, chlorhexidine, both topical and systemic analgesics, and oral 
cryotherapy[15, 16, 18]. Systemic analgesics commonly used for treatment include opioids, non-
steroidal anti-inflammatory agents, and acetaminophen[15]. Because of issues with dysphagia, 
oral administration of analgesics may be hampered. Thus, transdermal formulations are 
frequently utilized. Unfortunately, opioids are associated with well-documented side effects (e.g. 
addiction, tolerance, and dependence) and are frequently infective for controlling mucositis 
associated pain [19].  Thus, a search for other pain medications to manage mucositis induced 
pain is of clinical importance.  Since peripheral sensitization is one of the underlying 

 
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mechanisms for mucositis associated pain, it may be hypothesized that agents that are effective 
for neuropathic pain may modulate mucositis associated pain[17, 20] 
 
 
1.3  
Pain  
 
It is estimated that pain affects more than 20% of adults around the world making it one 
of the most common patient complaints[21]. Pain is often subdivided into two categories – acute 
and chronic.  Acute pain is believed to be an evolutionarily protective mechanism designed to 
protect the body from harmful stimuli and situations (ie rapidly moving one’s hand from the 
burning stove). Thus acute pain is the body’s defense system that produces reflexive actions to 
prevent severe tissue injury and allow time for healing. Chronic pain is defined as that which 
lasts beyond the ordinary duration of time that an insult or injury to the body needs to heal. 
Unlike acute pain, which has a biological role, chronic pain is a pathological process that causes 
severe impairment even when the insult or injury has healed.   
Two types of pain pathways that have been a target of pharmacological therapy include 
neuropathic pain and nocioceptive pain. Neuropathic pain results from a lesion or disease of the 
nervous system that causes abnormal neural activity in the neural pathways that signal pain[22]. 
Patients with neuropathic pain often describe sensations of “burning,” “pins and needles,” or 
“electrical stabbing pains.” Etiologies of neuropathic pain fall under four broad categories: 
(1)focal or multifocal lesions of the peripheral nervous system such as entrapment syndromes, 
postherpetic neuralgia, or diabetic mononeuropathy; (2) polyneuropathies such a vitamin 
deficiencies, HIV neuropathy, and hypothyroidism; (3) central nervous system lesions such as 
multiple sclerosis, thalamic infarcts, and syringomyelia; (4) complex neuropathic disorders such 
as complex regional pain syndromes (reflex sympathetic dystrophy and causalgia.[22] 
Alternatively, the nociceptive pain pathway detects noxious mechanical, thermal and 
chemical stimuli through their specialized free nerve endings (nociceptors) found in the skin, 
visceral organs, articular surfaces and periosteal surfaces [23]. Receptors responsible for the 
transduction of nociceptive signals include the Vanilloid Receptor (VR-1) and the Vanilloid-Like 
Receptor (VRL-1) [24]. Both of these receptors belong to the larger family of transient receptor 
potential (TRP) channels that resemble voltage-gated ion channels. Once the nociceptors are 
stimulated, afferent signals travel via the spinothalamic tracts to the brain synapsing in the 
sensory cortex where the pain signals are processed.  Recent research suggests that there are 
parallel pain pathways that project to secondary brain regions such as the amygdala, 
hypothalamus, and reticular formation that regulate the sensory discriminative aspects of pain 
(location, quality, and quantity of the pain) as well as the affective-motivational aspects of pain 
that are responsible for evoking fear, anxiety, and activation of the autonomic nervous system 
(the flight or fight response)[25-29]. Thus pain is a full perceptual experience that involves 
multiple sensory modalities that results in a constellation of systemic symptoms ranging from 
changes in mood, cognition dysfunction, as well as neurovegetative and somatic complaints.  
There are two mechanisms that are thought to facilitate persistent chronic pain and 
hyperalgesia – peripheral sensitization and central sensitization. Peripheral sensitization is 
thought to result from the interaction of nociceptors and the “inflammatory soup” of molecules 
from the injured or inflamed tissue. The release of bradykinin, cytokines, histamine, 
prostaglandins, growth factors, and extracellular protons create a chemical environment that 
interacts with nociceptors and pain nerve fibers, augmenting their response to stimuli. Thus 

 
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slightly painful stimuli and or otherwise non-painful stimuli are perceived as significantly more 
painful. Peripheral sensitization explains why medications such as non-steroidal anti-
inflammatory drugs (NSAIDS) and anti-histamines that inhibit the production of prostaglandins 
and histamine respectively are effective in managing pain. [30] 
 
Central sensitization results from an activity-dependent increase in the excitability of 
dorsal horn neurons of the spinal cord following repeated stimulation from nociceptive afferent 
signals. Following repeated stimulation, transcriptional changes of ionotropic NMDA receptors 
in the dorsal horn cells results in removal of the normal voltage-dependent magnesium ion block, 
increasing the time the channel is open. This is thought to increase the excitability of the dorsal 
horn cell. Thus, nociceptive afferents that would otherwise be subthreshold become sufficient to 
depolarize the dorsal horn neurons of the spinal cord pain pathways. Unlike peripheral 
sensitization, which is restricted to the site of tissue injury, the effects of central sensitization 
generalize to other inputs that arise from low-threshold mechanoreceptors. Under normal 
circumstances, these states of heighted pain response return to normal once the insult is removed 
and tissue healing is complete. [31] However in many pathological pain syndromes, these 
thresholds are never restored and previously innocuous stimuli result in symptoms of allodynia 
and hyperalgesia that can spread beyond the site of injury.  
 
1.4  
Gabapentin 
 
Gabapentin is a drug structurally similar to GABA that interacts with voltage calcium 
channels located throughout cortical brain tissue[32, 33]. Although labeled for treatment of 
partial seizures, Gabapentin’s unlabeled indications include treatment of neuropathic pain 
conditions such as restless leg syndrome, diabetic neuropathy, fibromyalgia and migraines [33-
35]. The question has been raised as to whether Gabapentin can decrease radiation-induced acute 
and chronic oral mucositis pain in head and neck cancer patients. The majority of data looking at 
Gabapentin in management of acute and chronic pain has taken been done in the setting of post-
operative management. A review of Gabapentin in the treatment of acute post-operative pain by 
Chang et all found that the administration of gabapentin was associated with post-operative 
reductions of  (1) rescue analgesics and pain scores in patients undergoing coronary artery by-
pass graft, (2) the requirements of antiemetics in patients undergoing neurological surgery and 
hysterectomy, and (3) a reduction in pain and narcotic use in patients undergoing lumbar spinal 
surgery at every time point [36]. A second study by Straube et all found that single 250 mg dose 
of Gabapentin was associated with 50% reduction in acute pain over 6 hours post-operatively 
(RB of 2.5 with 95% CI 1.2 to 5.0) in 15% of patients vs only 5% in controls as well as a  
decreased usage of rescue  medications [37] 
A study looking at the effects of Pregabalin, a drug structurally similar to Gabapentin, 
found that Pregabalin is effective at reducing neuropathic and inflammatory orofacial pain in rat 
models [38]. Gabapentin has also been found to improve dysphagia in patients with 
oropharyngeal squamous cell carcinoma (OPSCC). A case report of 10 head and neck cancer 
patients treated with gabapentin after failing other interventions found that three 300 mg doses of 
gabapentin daily eliminated neuropathic pain in 8 of the 10 patients with partial relief of 
symptoms in the remaining 2 [39].  A study by Starmer et all found that prophylactic treatment 
of Gabapentin in patients with OPSCC was associated with delayed onset of PEG use (3.7 vs 
2.29 week; P=0.013) and earlier removal of their PEG tubes (7.29 vs 32.56 weeks; P=0.039) than 
controls [40].  Thus it is plausible that treatment of oral mucositis with Gabapentin can be 

 
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hypothesized to improve not only pain but also improve quality of life parameters such as 
swallowing and nutritional intake.  
A retrospective study evaluated this question. Investigators conducted a chart review of 
42 patients with head and neck malignancies treated with concurrent chemoradiotherapy using an 
intensity-modulated radiotherapy technique. Pain outcomes for patients treated with gabapentin 
for prevention of mucositis associated pain were compared to pain outcomes for patients using 
standard supportive care. Results found that preventive administration of gabapentin reduced 
overall pain levels and the total dose of opioids utilized [34].  Although the data is intriguing, 
there are numerous limitations to this study. First, the study was retrospective. Second, patients 
were not randomized and third, outcomes were not pre-established. None-the-less, the data 
would support further investigation of gabapentin as chronic preventive measures for mucositis 
associated pain in patients undergoing chemoradiation for head and neck cancer 
 
1.6    Study Summary: 
 
The overall goal of this study is to determine whether or not Gabapentin can reduce 
mucositis associated pain in head and neck cancer patients undergoing chemoradiation. Patients 
seen in the Oncology Clinic for routine surveillance will be informed about the study and asked 
if they interested in participation. Interested patients will be asked to sign an informed consent. 
They will then be randomized into to two arms—standard of care and standard of care plus 
gabapentin. Prior to chemoradiation therapy, subjects will undergo education on chemoradiation 
as well as foundations of oral care.  Subjects will be asked to complete a demographic survey, 
the Head and Neck Symptom Survey 2.0 plus the General Symptom Survey (VHNSS v2.0 plus 
GSS), the Profile of Mood States – short form (POMS-SF), the Neurotoxicity Rating Scale 
(NRS), the and a Quality of Life (QOL) assessment as outlined below. Subjects will also be 
requested to maintain a pain diary that will be used throughout the study to assess their pain and 
their mucositis will be graded weekly during their visits.  
 
Upon completion of therapy, the data will be collected and stored in a secure password protected 
database and the patient’s study participation will end.  We anticipate the study duration to be 2 
years.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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2.0 
Specific Aims 
 
Specific Aim 1: To determine whether Gabapentin used as a preventive measure during 
chemoradiation can reduce radiation-induced mucositis associated pain in head and neck cancer 
patients as measured by: 1) pain scores on the Vanderbilt Head and Neck Symptom Survey 
(VHNSS version 2.), and 2) analgesic use.  
 
Hypothesis 1.1: Compared to controls, patients using Gabapentin during radiation-based 
therapy will have a 1.5 point decreases in self-reported oropharyngeal pain (on a scale of 
0 to 10) week six of radiation.   
 
Hypothesis 1.2: Compared to controls, patients using Gabapentin during radiation-based 
therapy will have a 20% decrease in opioid use (as measured in morphine equivalents) at 
week six of radiation.  
 
Specific Aim 2: To determine whether pain control is associated with weight loss (in pounds) 
and duration of use of percutaneous endoscopic gastrostomy utilization (in days).   
 
Hypothesis 2.1 Patients with less pain will have decrease weight loss.  
 
Hypothesis 2.2 Patients with less pain will have a shorter duration of PEG placement.   
 
Specific Aim 3: To assess the safety (grade 3 or 4 adverse events) and tolerability of using 
gabapentin (discontinuation of drug due to side effects - yes or no).  
 
Specific Aim 4: To correlate pain severity with frequency and severity of general systemic 
symptoms.  
 
 
3.0 
Inclusion/Exclusion Criteria 
  
Inclusion Criteria 
• Histologically proven cancer of the head and neck cancer  
• Stage 3 or 4 under the AJCC and IUCC staging System OR patients with Stage 1 or 2 
disease who will receive radiation equivalent to patients with Stage 3 or 4 disease  
• Planned primary or adjuvant chemoradiation therapy 
• Willing and able to provide informed consent 
• Age ≥ 21 years 
• English speaking 
 
Exclusion Criteria 
• Currently on gabapentin 
• Prior non-tolerance of gabapentin  
• History of seizure disorder 
 
 

 
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4.0 
Enrollment/Randomization 
 
A total of 150 patients planned for primary and adjuvant radiation with or without 
chemotherapy will be recruited. These patients will be identified in the Vanderbilt Oncology 
Clinic and at head and neck tumor board. Study staff will approach patients to discuss the study 
and the possibility of patient participation therein.  The objectives and requirements of the study 
will be described to the patients and any questions will be answered. Interested patients will be 
given consent for to review.  If the patient volunteers to participate in the study, the consent will 
be signed and they will be given a copy for their records.  The original copy will be retained in 
the study files. The patient will be assigned to the usual care or usual care plus gabapentin arm of 
the study according to the next group assignment specified in the randomization list generated 
via the use of a computer-generated, permuted block program developed by Co-I Dietrich.  
 
5.0 
Study Procedures 
 
5.1 Chemoradiation:  
 
Chemotherapy and radiation will be instituted per standard of care. There will be no alterations 
in standard of care as a result of participation in this study.  Disease treatment related data will be 
obtained through chart review after the completion of therapy. 
 
5. 2 Study Treatment: 
 
Patients will be randomized to Arm 1 (Usual Care) or Arm 2 – (Usual Care plus Gabapentin). 
 
Arm 1: Usual Care:  
 
Usual care will include the following:  
1. Oral health measures including brushing, flossing, and the use of fluoride toothpaste 
2. Oral rinsing with baking soda and salt water gargles every 2-3 hours while awake 
3. Miracle mouthwash formulated to include topical lidocaine, Benadryl, and Maalox;  
4. Nonsteroidal anti-inflammatories around the clock to treat pain and inflammation  
5. Opioid analgesics to include a fixed and breakthrough medication.  
 
Patients will undergo an education session at the beginning of treatment to review foundations of 
oral care and pain management.  
  
 
 
 
 
 
 
 
 

 
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Arm 2: Usual Care plus Gabapentin.  
 
Patients will receive all measures for Arm 1 PLUS Gabapentin.  Gabapentin will be dose 
escalated using a slow escalation schema to minimize the sedating effects of medication and 
avoid undue toxicities:  
 
Week 1: Gabapentin 100 mg PO 3 times a day  
Week 2: Gabapentin 300 mg PO 3 times a day.   
Week 3: Gabapentin 600 mg PO 3 times a day.   
Week 4 onward: Gabapentin 900 mg PO 3 times a day. 
 
 
The highest tolerated dose of gabapentin will continue throughout treatment. Missed doses, 
though regrettable, are part of any patient-administered medication and will not be considered 
deviations for this study as we are studying practical efficacy. After completion of therapy, 
mucositis is expected to resolve at a variable rate (1 to 3 months post treatment). Gabapentin will 
be continued until mucositis resolves and pain subsides. Patients will be weaned off opioids 
prior to initiation of gabapentin de-escalation. Once opioids have been weaned, de-escalation of 
gabapentin will be initiated. Since the rate at which patients can be weaned of pain medications 
is variable, de-escalation will be managed by the treating physician. Abrupt discontinuation of 
gabapentin will be discouraged in order to avoid symptoms related to withdrawal.  
 
5.3 Dose Modifications: 
 
Prior to each dose escalation, patients will be assessed for side effects related to gabapentin.  
 
• Patients who are tolerating the current dosing schedule will undertake an escalation to the 
next dose level.  
• If patients have mild to moderate side effects related to gabapentin, no further dose 
escalation will be undertaken 
• If patients develop severe side effects attributable to gabapentin, gabapentin will be held 
until the side effects have totally resolved and then restarted at the last known tolerated 
dose level.  
• Although rare, severe mood alterations and suicidal thoughts have been associated with 
this agent. Should patients experience these symptoms, gabapentin will be permanently 
discontinued. 
 
5.4 Route of Administration: 
 
Gabapentin is usually taken orally. Gabapentin may also be crushed and given via feeding tube if 
the patient is unable to swallow the tablet.   
 
5.5 Pain Management: 
 

 
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Pain management for tumor and treatment related toxicities will be at the discretion of the 
treating physician.  Opioid and adjuvant use will be documented for study purposes. At the 
completion of study, patients on Arm 1 may be started on gabapentin if they have uncontrolled 
mucositis associated pain.  For patients assigned to Arm 1, the treating physician will manage the 
utilization of gabapentin during the post-treatment phase 
 
5.6 Study Visits: 
In order to minimize inconvenience to patients under study, study visits will coincide with 
scheduled treatment. This may introduce a degree of variability in the timing of weekly visits and 
follow-up visits which will be considered acceptable accept in cases where explicit visit timing is 
dictated elsewhere in the protocol. Weekly on treatment visits that are more than 1 week late will 
be considered missing. 
 
Baseline:  
Prior to initiating therapy, patients will undergo education sessions with study staff.   The 
educational intervention will include a discussion of oral health foundations as well as a 
discussion of pain management. This education is standardly applied to all VUMC patients 
undergoing radiation therapy for HNC and will not be otherwise documented. In addition, 
patients will also be given written material to review. Patient will be given a pain diary and 
instructed on its use. Baseline pain medication use will be documented. Patients will complete 
the demographic survey. Patients randomized to gabapentin will be given a prescription for 
gabapentin with dose escalation as noted in the treatment section.  Patients who do not have 
insurance or who are unable to afford gabapentin will be provided with medication from the 
indigent pharmacy.  All baseline assessments must be done within 4 weeks of starting concurrent 
chemoradiation. 
 
 
 
Weekly On Treatment Visits: 
 
Starting with the initiation of concurrent chemoradiation, patients will be evaluated on a weekly 
basis.  The evaluation will include:  
1) review of the weekly pain survey  
2) for patients on gabapentin (Arm 2) --we will review their compliance log and identify 
any barriers to compliance and strategies to improve their compliance  
3) adjustment of pain regimen 
4) completion and review of the Vanderbilt head and neck symptom survey  
5) mucositis grading.  
 
End-of-Treatment Visit: 
 
Patients will undergo an evaluation at their final radiotherapy visit or within 2 weeks after.  This 
will include the following:  
1) review of the monthly diary survey 
2) for patients on gabapentin (Arm 2) --we will review their compliance log and identify 
any barriers to compliance and strategies to improve their compliance 

 
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3) adjustment of pain regimen 
4) completion and review of the Vanderbilt head and neck symptom survey 
5) mucositis grading.  
 
 
 
 
 
6.0 Study Measures: 
 
6.1 Mucositis Grading: 
Patients will have an oral exam twice a week as part of standard of care.  Mucositis will be 
graded based on the World Health Organization criteria.  Mucositis assessments will be done by 
trained study staff. 
 
6.2 Patient Reported Outcome Measures: 
 
Study Visit:  The study nurse will meet with the patient at baseline, weekly during radiation therapy, and 
at 1, 2 and 3 months post-treatment.  At each study visit the study nurse will 1) administer appropriate 
questionnaires, 2) review the patient’s pain diary and compliance diary, 3) document concurrent 
medications, 4) document toxicities based on CT CAE criteria 4.0, 5) identify and prepare reports for any 
adverse events, 6) document any dose adjustments in pain medications as recommended by the physician 
or nurse practitioner, and 7) educate the patient regarding medication dose and schedule.   
 
As these patient reported outcome measures represent outcomes of interest for the study, they will not be 
altered by study staff due to missingness as changes would threaten the validity of the tool. 
 
Appendix A:  Demographics:  
 
Includes date of birth, gender, race, education, marital and employment status, area of residence, 
presence of any co-morbid conditions, medical history, alcohol use, tobacco use, and dietary 
habits. To be completed by the patient –approximate time for completion is 3 to 5 minutes. 
 
Appendix B:  Vanderbilt Head and Neck Symptom Survey version  2.0 (VHNSS 2.0) 
 
This 61-item instrument has been developed specifically to measure acute and late symptoms in 
HNC patients. Items are summed to provide a total score as well as 13 domain scores. Studies 
have reported good internal consistency for the total VHNSS scale (alpha=0.94) and five 
subscales (i.e., swallow, nutrition, mucous/dry mouth, pain, voice) (alphas=0.77-0.93), and 
adequate convergent and divergent validity. Mean scores on each VHNSS subscale can range 
from 0 (none) to 10 (a lot). Higher scores reflect greater symptom burden. To be completed by 
the patient – approximate completion time less than 10 minutes.  
 
Appendix C:  Pain Survey:  
 
Patients will be asked to complete a pain survey that will allow the healthcare providers and 
study investigators to appropriately assess and monitor the patient’s pain throughout the study. 

 
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Patients will be asked to mark their average pain , current pain and their worst pain every 
week on a scale from 1-10, 10 being the worst pain they have ever felt. They will also be asked 
to document the number of rescue doses used each day.  
 
Appendix D:  Compliance Diary: 
 
Patients on the gabapentin arm will be asked to maintain a complete a survey to document 
compliance with gabapentin. The reason for missed doses will be captured.  
 
Appendix E:  Profile of Mood States-Short Form:  The Profile of Moods states is a 37-item scale 
is composed of six subscales: depression, vigor, confusion, tension, anger and fatigue. 
Cronbach’s alphas ranged from .78 to .91. It correlates will with other measures of mood and 
physical function, yet is has the benefit of a short administration time.   
 
Appendix F:  Neurotoxicity Rating Scale (NRS): The NRS is a 37 item instrument whose items 
reflect symptoms associated with neurotoxicity of medical treatment [41] 
Participants rate the severity of all of the 37 item, 5 point Likert-like scale that rates 
neuropsychiatric symptoms on a scale of “not present” to “extremely severe.”  
 
Appendix G:  Quality of Life  QOL will be measured using Cantril’s Ladder, a single item self-
anchoring scale ([42]; [43]).  The measure asks patients to rate their current quality of life on a 
scale ranging from 0 to 10, with higher scores indicating better overall quality of life. 
Discriminant validity has been supported by significantly lower scores in patients with 
rheumatoid arthritis than in healthy controls ([44]). Construct validity has been supported by a 
positive relationship between scores on to social role retention in survivors of bone marrow 
transplantation ([45]). A 5 item domain-specific QOL questionnaire will also be used.    
 
Appendix H: Disease and Treatment Data Form – Data related to the patient’s cancer and treatment 
including diagnosis date, location, stage of disease, surgical treatment, medical oncology treatment, and 
radiation oncology treatment will be determined by medical record review at the time of the study visit 
and will be completed by study nurse or study providers.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix I: Studies to be Done:  
 
 
Baseline¥ Week 
1 
Week 
2 
Week 
3 
Week 
4 
Week 
5 
Week 
6 * 
Week 
7 * 
1,2 3 
Months 
post tx 
Study Visit 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Chemoradiation  
Teaching  
X 
 
 
 
 
 
 
 
 
Foundations of 
Oral Care 
X 
 
 
 
 
 
 
 
 
Foundations of 
Pain 
Management 
X 
 
 
 
 
 
 
 
 
Randomization  
X 
 
 
 
 
 
 
 
 
Gabapentin 
Arm 2 Only 
 
X 
X 
X 
X 
X 
X 
X 
X 
Mucositis 
Grading  
X 
X 
X 
X 
X 
X 
X 
X 
X 
Demographic 
Survey 
X 
 
 
 
 
 
 
 
 
VHNSS 
Version 2.0 
 
X 
X 
X 
X 
X 
X 
X 
X 
Pain Survey 
 
X 
X 
X 
X 
X 
X 
X 
X 
Compliance 
Survey  
Arm 2 Only 
 
X 
X 
X 
X 
X 
X 
X 
X 
Neurotoxicity 
Scale 
X 
 
 
 
 
 
X 
 
X 
(month 
3 only) 
POMS 
X 
 
 
 
 
 
X 
 
X 
(month 
3 only) 
QOL 
X 
 
 
 
 
 
X 
 
X 
(month 
3 only) 

 
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Disease and 
Treatment 
Form 
X 
 
 
 
 
 
 
 
 
 
¥ All baseline assessments must be done within 4 weeks before starting concurrent chemoradiation. 
* Weekly assessments will continue until the completion of chemoradiation which may vary between 5 
and 7 weeks. 
 
An End of Treatment Visit will be conducted 2 weeks after Chemoradiation therapy  
 
 
 
 
 
 
 
 
7.0    Risks of Investigational Agents/Devices (side effects) 
Gabapentin: 
• >10%  
o Central Nervous System: Dizziness (IR 17% - 28%, ER 11%), Drowsiness (IR 
19%-21%; ER 5%), Ataxia (1% to 13%), Fatigue (11%) 
• 1-10%  
o Cardiovascular: Peripheral edema (IR: 2% to 8%; ER: 4%), vasodilatation (1%) 
o Central nervous system: Hostility (children 5% to 8%), tremor (7%), emotional 
lability (children 4% to 6%), hyperkinesia (children 3% to 5%), headache (ER: 
4%; IR: 3%), abnormality in thinking (2% to 3%; children 2%), abnormal gait 
(2%), amnesia (2%), depression (2%), nervousness (2%), pain (ER: 1% to 2%), 
hyperesthesia (1%), lethargy (ER: 1%), twitching (1%), vertigo (ER: 1%) 
o Dermatologic: Pruritus (1%), skin rash (1%) 
o Endocrine & metabolic: Weight gain (IR: Adults and children 2% to 3%; ER: 
2%), hyperglycemia (1%) 
o Gastrointestinal: Diarrhea (IR: 6%; ER: 3%), nausea and vomiting (3% to 4%; 
children 8%), xerostomia (IR: 2% to 5%; ER: 3%), constipation (IR: 1% to 4%; 
ER: 1%), abdominal pain (3%), dyspepsia (IR: 2%; ER: 1%), dry throat (2%), 
dental disease (2%), flatulence (2%), increased appetite (1%) 
o Genitourinary: Impotence (2%), urinary tract infection (ER: 2%) 
o Hematologic & oncologic: Decreased white blood cell count (1%), leukopenia 
(1%) 
o Infection: Infection (5%) 
o Neuromuscular & skeletal: Weakness (6%), back pain (IR: 2%; ER: 2%), 
dysarthria (2%), limb pain (ER: 2%), myalgia (2%), bone fracture (1%) 
o Ophthalmic: Nystagmus (8%), diplopia (1% to 6%), blurred vision (3% to 4%), 
conjunctivitis (1%) 
o Otic: Otitis media (1%) 
o Respiratory: Rhinitis (4%), bronchitis (children 3%), nasopharyngitis (ER: 3%), 
respiratory tract infection (children 3%), pharyngitis (1% to 3%), cough (2%) 
o Miscellaneous: Fever (children 10%) 

 
Protocol Version #: 13 
 
15 
Protocol Date: 11/28/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.0   Reporting of Adverse Events or Unanticipated Problems involving 
Risk to Participants or Others 
 
8.1 Safety Monitoring:  
 
Participants will be educated regarding signs and symptoms related to adverse events (AEs) 
requiring urgent or emergent medical care. All AEs grade 3 or higher will be documented, reviewed 
by Dr. Murphy. Any contributing factors will be reviewed, and strategies to prevent further 
complications will be developed and implemented. Dr. Murphy will meet with study staff 
annually to evaluate any other safety concerns. AEs will be graded using CTCAE criteria 4.0. All 
unexpected grade 3, 4 or 5 AEs possibly or probably related to study drug will be reported to the 
IRB. 
 
Data Safety Monitoring Board:  
 
Four experts will be proposed for the DSMB members. The DSMB members must not be 
co-investigators or consultants, not have been directly involved in protocol development, not 
have close current or recent affiliations with the study, nor supervise persons who are directly 
involved in the study. We will make effort to include at least one representative with expertise in 
biostatistics, clinical trials methodology, and head and neck oncology. 
  
The DSMB will oversee and monitor the activities related to implementing the study to 
ensure the safety of participants, adherence to the study protocol, overall performance of the trial 
components, integrity of data, and security of data management. The DSMB will meet annually, 
at the time of interim analysis and on an as-needed basis if significant issues arise that impact the 
study participants or any study activities. For each DSMB meeting, progress reports will be 
prepared and provided to DSMB members by the PI and mentor. The DSMB will prepare an 
annual safety report, summarizing the efforts and findings through the annual monitoring.  
 
 

 
Protocol Version #: 13 
 
16 
Protocol Date: 11/28/2017 
9.0   Study Withdrawal/Discontinuation 
 
Patients may withdraw consent at any time during the study participation without bias or 
alteration in their ongoing cancer care.  The reason for discontinuation or withdrawal will be 
documented in the study record. 
 
The investigators reserve the right to take patients off of study for failure to comply with study 
parameters, if patients have undo toxicity secondary to gabapentin, or if the investigators feel it 
is in the best interest of the patient. 
 
10.0 Statistical Considerations and Sample Size Justification 
 
General evaluation and analysis plan: Statistical software will be used to summarize the data 
collected and to test study hypotheses. Intent-to-treat principles will be used for all analyses. An 
interim analysis of the VHNSS pain scores  will be conducted when 50% of the participants have 
been randomized and have completed the 3 month follow-up period. To maintain the final 
overall alpha of P < 0.05, the Haybittle-Peto approach will be used: the trial will be stopped at 
that point if the symmetric stopping boundaries of P<0.001 are met. The interim analysis will 
only be used for this purpose, i.e. no futility analyses will be conducted. 
 
Management of Missing Data: In-depth investigations of patterns of missing data will be 
undertaken. Given the longitudinal nature of this study, we expect two types of missing data: 1) 
randomly missing responses to items within the self-report measures (e.g., VHNSS) 
and 2) non-randomly missing lost-to-follow up (LTF) assessments. Our proposed sample size 
accommodates up to 30 LTF (i.e., up to 20% of those randomized) to arrive at a total analysis 
sample size of 120. Randomly missing item response data will be handled via protocols specified 
by the instrument developers. When there is no specified protocol, if the participant has 
completed 75% or more of the items on a particular instrument, prorated scores for that 
instrument will be generated using available item responses. Non-randomly missing data will be 
assessed to determine whether it provides clinically important information and implications for 
generalizability of findings. All efforts as outlined by White et al. (2011) for handling missing 
outcome data in an RCT-ITT analysis will be conducted. 
 
[2] White IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in 
randomised trials with missing outcome data. BMJ 2011;342:d40 
 
Analyses for study aims. Graphical and descriptive statistical summaries will be generated for 
all study variables. Evaluation of the key outcome variable data distributions (VHNSS mouth 
pain scores, opioid dose) will inform the required test distribution (e.g., normal, log-normal). 
Mixed-level general linear modeling will be used to test study hypotheses. Given that patients 
will have varying VHNSS pain scores prior to beginning radiated, those baseline values will be 
included as a covariate in the analyses of outcomes [EOT: VHNSS pain scores (H1.1); opioid 
use (H1.2); weight loss (H2.1); duration of PEG (H2.2); general symptoms (Aim 4)]. Frequency 
distributions will summarize the safety and tolerability outcomes (Aim 3). All tests of statistical 
significance will maintain maximum Type I error of 0.05 (p < 0.05). 
 

 
Protocol Version #: 13 
 
17 
Protocol Date: 11/28/2017 
Sample size justification. The proposed sample size was based on typical VHNSS pain score 
values during/end-of-treatment in prior studies (M=4.5, SD=2.8). A total sample size of 120 
patients (60 per arm) who complete the protocol will provide 80% statistical power (2-tailed 
alpha=0.05) to detect a decrease of 1.5 points on the VHNSS pain scale due to the addition of 
gabapentin to usual care. Given a change of 2.0 points on the scale is proposed to be clinically 
meaningful, this slightly larger sample size will provide coverage in the case that our sample 
values are slightly more variable than those observed in our prior studies. A total sample size of 
120 will also enable us to detect correlations as small 0.25(6.3% shared variance) with 80% 
power and 2-tailed alpha=0.05. We expect clinically meaningful associations to be larger than 
this value. 
 
 
 
 
 
 
11.0 Data Management and Safety Monitoring Plan 
 
Data Management: All questionnaires will be completed on line using REDCAP. Hard copy data 
regarding tumor, treatment, pain diaries and adverse events will be double-entered into a 
password-protected database. Paper copies will be stored in a locked cabinet in a secure room. 
All data will be coded without any identifiable information. Only the PI and mentor will maintain 
a key that links participants to ID number in a password-protected database on a secure server.  
Paper copies will be destroyed after study completion and publication of results. The PI and/or 
mentor will monitor all databases at least monthly to ensure data integrity.  
 
 
12.0 Privacy/Confidentiality Issues 
 
The confidentiality of records that could identify subjects must be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).  
There is no information to be collected that might increase the risk of a breach of confidentiality. 
 
Participant’s personal information will remain confidential and will not be used if study 
information is published or presented at a scientific meeting.  Identifying information can be 
marked as such in REDCap so that it will not be released when the data is downloaded from the 
database. 
 
13.0 Follow-up and Record Retention 
 
All data will be recorded in the electronic REDCap database, which is a secure, password-
protected database. In addition, hard copies of the consent forms, questionnaires, surveys, and 
digital photographs will be stored in a locking file cabinet. Only the PI and research team have 
access to the electronic database and the file cabinet. Once the study results have been reported, 
the database will no longer be accessed and all hard copies will be destroyed. 

 
Protocol Version #: 13 
 
18 
Protocol Date: 11/28/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Keefe, D.M., et al., Updated clinical practice guidelines for the prevention and treatment 
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Harris, D.J., Cancer treatment-induced mucositis pain: strategies for assessment and 
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Goldberg, D.S. and S.J. McGee, Pain as a global public health priority. BMC Public 
Health, 2011. 11: p. 770. 
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Baron, R., Mechanisms of disease: neuropathic pain--a clinical perspective. Nat Clin 
Pract Neurol, 2006. 2(2): p. 95-106. 
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Invest, 2010. 120(11): p. 3760-72. 
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in mediating high threshold noxious heat-sensitivity in rat cultured primary sensory 
neurons. Eur J Neurosci, 2002. 16(8): p. 1483-9. 
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Ploner, M., et al., Parallel activation of primary and secondary somatosensory cortices in 
human pain processing. J Neurophysiol, 1999. 81(6): p. 3100-4. 
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nociceptive somatosensory information in the human primary and secondary 
somatosensory cortices: evidence from dynamic causal modeling of functional magnetic 
resonance imaging data. J Neurosci, 2011. 31(24): p. 8976-85. 
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Simons, L.E., et al., The human amygdala and pain: evidence from neuroimaging. Hum 
Brain Mapp, 2014. 35(2): p. 527-38. 
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Mutso, A.A., Abnormalities in Hippocampal Functioning with Persistent Pain. 2012. 
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Schlereth, T. and F. Birklein, The sympathetic nervous system and pain. Neuromolecular 
Med, 2008. 10(3): p. 141-7. 
30. 
Schaible, H.G., A. Ebersberger, and G. Natura, Update on peripheral mechanisms of 
pain: beyond prostaglandins and cytokines. Arthritis Res Ther, 2011. 13(2): p. 210. 
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Latremoliere, A. and C.J. Woolf, Central sensitization: a generator of pain 
hypersensitivity by central neural plasticity. J Pain, 2009. 10(9): p. 895-926. 
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Clarke, H., et al., The prevention of chronic postsurgical pain using gabapentin and 
pregabalin: a combined systematic review and meta-analysis. Anesth Analg, 2012. 
115(2): p. 428-42. 
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Todd, R.D., et al., Gabapentin inhibits catecholamine release from adrenal chromaffin 
cells. Anesthesiology, 2012. 116(5): p. 1013-24. 
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Bar Ad, V., et al., Gabapentin for the treatment of pain syndrome related to radiation-
induced mucositis in patients with head and neck cancer treated with concurrent 
chemoradiotherapy. Cancer, 2010. 116(17): p. 4206-13. 

 
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35. 
Moore, R.A., Gabapentin for chronic neuropathic pain and fibromyalgia in adults. 
2011(3): p. Cd007938. 
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Chang, C.Y., et al., Gabapentin in Acute Postoperative Pain Management. Biomed Res 
Int, 2014. 2014. 
37. 
Straube, S., Single dose oral gabapentin for established acute postoperative pain in 
adults. 2010(5): p. Cd008183. 
38. 
Hummig, W., C. Machado Kopruszinski, and J.G. Chichorro, Pregabalin reduces acute 
inflammatory and persistent pain associated with nerve injury and cancer in rat models 
of orofacial pain. J Oral Facial Pain Headache, 2014. 28(4): p. 350-9. 
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Sist, T.C., et al., Experience with gabapentin for neuropathic pain in the head and neck: 
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Starmer, H.M., et al., Effect of gabapentin on swallowing during and after 
chemoradiation for oropharyngeal squamous cell cancer. Dysphagia, 2014. 29(3): p. 
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Protocol Version #: 13 
 
21 
Protocol Date: 11/28/2017 
Appendix A: Socio-demographic Data Form 
Version date: 3-5-2015 
Study #___________________  ID# __________________ Coder #____________________ 
Date_____________________ 
Patient Interview; 
1. What is your birthdate?     ____/____/_______ (month/day/year) 
 
2. Gender:  
(1) Female___(2) Male____ 
(3) Other____(4) Do not care to respond___ 
 
3.1 What is your race? 
(1) American Indian/Alaskan Native____   
(2) Asian____   
(3) Native Hawaiian or Other Pacific Islander 
      _____ 
(4) Black or African American_____ 
(5) White_____ 
(6) Other ______  
3.2 What is your ethnicity? 
(1) Not Hispanic ______ 
(2) Hispanic _______ 
 
4. What is the highest grade of education you completed? (Please circle) 
 1      2     3     4     5     6    7    8    9   10   11 12 (high school) 13   14    15   16  (college)      
17   18  (master)  19   20  (doctorate) 
 
5. What is your marital status?  
(1) Single____    
(2) Single, living with partner_____          
(3) Married_____ 
(4) Widowed____    
(5) Other____ 
 
6. What is your current employment status? 
(1) Employed full time____      
(2) Employed part time____     
(3) Homemaker____  
(4) Retired_____                         
(5) Unemployed_____                  
(6) Other____ 
 
7. What best describes your area of residence? 
(1) City___ (2) Country ___ (3) Other___ 
Version date: 10-15-2014 

 
Protocol Version #: 13 
 
22 
Protocol Date: 11/28/2017 
Study #___________________  ID# __________________ Coder #____________________ 
Date_____________________ 
 
8. Health Maintenance 
8.1 Have you ever used or smoked tobacco? 
(1) No  ___ 
(2) Yes ___ 
 
What type of tobacco have you used (check all that apply)? 
Cigarettes ___, Cigars ___, Pipe ___, Dip ___, Plugs/Chaw ___, Other ___ 
 
8.2 Have you quit smoking tobacco? 
No ___ 
Yes ___; When____________ 
 
8.3. Have you ever used or smoked Marijuana? 
No ___ 
Yes ___ 
Do not care to respond ___ 
 
# marijuana uses per day ____ 
Age started using marijuana ___ 
Years using marijuana ___ 
 
8.4. Have you quit using marijuana? 
No _____ 
Yes _____; Marijuana quit date ___ 
Do not care to respond _____ 
 
8.5 Drinking Alcohol 
(1) No ____ 
(2) Yes ____ 
_____years _____ times per week 
(3) Quit ______When__________ 
(4) Not Quit ______ 
_____ times per week (Current) 
 
9. What is your insurance coverage? 
(1) Medicare____ (2) Medicaid____  
(3) TennCare____ (4) Private Insurance____ 
(5) HMO____         (6) None_____                      
(7) Other_____ 
 
10. Do you have any medical problems?  
(1) No 
(2) Yes (e.g., HBP, DM, Obesity, Injury History) _____________________________________ 

 
Protocol Version #: 13 
 
23 
Protocol Date: 11/28/2017 
 
11. What is your yearly household income? 
(1) $10,000 or less____      
(2) $10,001 to $ 20,000____    
(3) $20,001 to $ 30,000____ 
(4) $30,001-$40,000___     
(5) $ 40,001 to $50,000____    
(6) $50,001 to $60,000 ____ 
(7) Over $60,000____         
(8) Do not care to respond____ 

 
Protocol Version #: 13 
 
24 
Protocol Date: 11/28/2017 
Appendix B: The Vanderbilt Head and Neck Cancer Symptom Survey (version 2.0) Plus 
General Symptom Survey 
Name:_____________________________________________________Date:_____________ 
 
Directions: Please answer the following questions by checking the appropriate box. 
 
1. I currently have a feeding tube in place. 
⁮  Yes ⁮ No 
2. I have teeth  ⁮  Yes  ⁮ No 
3. I use dentures   ⁮  Yes  ⁮ No 
 
Directions:  Please read all questions and circle the number that best describes your 
symptoms over the past week.  In general, a “0” indicates the least amount of problems 
with a particular symptom and “10” indicates the most problems. 
 
1. 
I have been losing weight 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
None  
 
 
 
 
 
 
 
 
A lot 
2. 
I have lost my appetite 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Normal 
 
 
 
 
 
 
 
 
 
No 
appetite 
3. 
I have to use liquid supplements (like Ensure® or Boost®) to maintain my weight 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
None  
 
 
 
 
 
 
 
All liquid 
supplements 
4. 
I have trouble maintaining my weight because of swallowing problems 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
None  
 
 
 
 
 
 
 
 
A lot 
5. 
I have trouble eating certain solid foods (like hard to chew, crumbly, or sticky foods) 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
None  
 
 
 
 
 
 
 
 
A lot 
6. 
I have trouble drinking thin liquids (like water, tea and Ensure®) 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
None  
 
 
 
 
 
 
 
 
A lot 
7. 
Food gets stuck in my mouth 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
8. 
Food gets stuck in my throat 
 

 
Protocol Version #: 13 
 
25 
Protocol Date: 11/28/2017 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
9. 
I choke or strangle on liquids 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
10. 
I choke or strangle on solid foods 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
11. 
I cough after I swallow 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
12. 
Swallowing takes great effort 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
13. 
It takes me longer to eat because of my swallowing problem 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
14. 
I have problems with dry mouth 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Severe 
15. 
Problems with dry mouth make chewing and swallowing difficult 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
16. 
Problems with dry mouth affect my ability to sleep  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
17. 
Problems with dry mouth affect my ability to talk  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
18. 
I have thick mucous or phlegm 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
19. 
Mucous causes me to choke or gag 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 

 
Protocol Version #: 13 
 
26 
Protocol Date: 11/28/2017 
20. 
Mucous causes difficulty swallowing  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
21. 
Mucous causes difficulty sleeping  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
22. 
I have sores in my mouth or throat that cause pain 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
No Pain 
 
 
 
 
 
 
 
 
 
Severe 
pain 
23. 
Mouth or throat pain causes difficulty swallowing  
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
24. 
Mouth or throat pain causes difficulty speaking  
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
25. 
My average pain level over the last week has been….. 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
No pain 
 
 
 
 
 
 
 
 
 
Severe 
pain 
26. 
My worst pain level over the last week has been…. 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
No pain 
 
 
 
 
 
 
 
 
 
Severe 
pain  
27. 
The average relief from my pain medication is….   ⁮ Not Applicable, I am not on pain 
medications 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
No relief 
 
 
 
 
 
 
 
 
Total  relief 
28. 
Pain causes difficulty sleeping  
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
29. 
I have trouble speaking  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Never  
 
 
 
 
 
 
 
 
Always 
30. 
My voice is hoarse 

 
Protocol Version #: 13 
 
27 
Protocol Date: 11/28/2017 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Not at all 
 
 
 
 
 
 
 
 
Very Hoarse 
31. 
I have trouble being understood because of my speaking or hoarse voice 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
32. 
I have trouble with my hearing 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
None  
 
 
 
 
 
 
 
 
Severe  
33. 
My taste is altered  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
None  
 
 
 
 
 
 
 
 
A lot 
34. 
I have less desire to eat due to taste change 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
35. 
My taste changes have altered the foods that I choose to eat  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
36. 
My taste changes have caused me to decrease the amount of food I eat  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
37. 
My sense of smell has changed  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Not at all 
 
 
 
 
 
 
 
 
Very much 
38. 
I have altered what I eat due to a change in my sense of smell 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Not at all 
 
 
 
 
 
 
 
 
Very much 
39. 
I have difficulty chewing because of my teeth or dentures…⁮ Not applicable, I do not 
have teeth or dentures 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
None  
 
 
 
 
 
 
 
 
Severe 
40. 
My teeth are sensitive to hot, cold or sweet foods   ⁮ Not applicable, I do not have
 
teeth 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
  
Not at all 
 
 
 
 
 
 
 
 
Very Sensitive 
41. 
My teeth feel looser ⁮ Not applicable, I do not have teeth 

 
Protocol Version #: 13 
 
28 
Protocol Date: 11/28/2017 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Not at all 
 
 
 
 
 
 
 
 
Very Loose 
42. 
My teeth are cracking or chipping   ⁮ Not applicable, I do not have teeth 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Not at all 
 
 
 
 
 
 
 
 
Severe 
43. 
I have trouble with my dentures ⁮ Not applicable, I do not have dentures 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
None  
 
 
 
 
 
 
 
 
A lot 
44. 
I have a burning sensation in the lining of my mouth and throat  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
  
None  
 
 
 
 
 
 
 
 
Very Painful 
45.  
The lining of my mouth and throat is sensitive to spicy, hot or acidic foods 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Not at all 
 
 
 
 
 
 
 
 
Very Sensitive 
46. 
The lining of my mouth and throat is sensitive to dryness 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Not at all 
 
 
 
 
 
 
 
 
Very Sensitive 
47. 
Burning pain in the lining of my mouth and throat changes what I eat  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
  
Never  
 
 
 
 
 
 
 
 
Always 
48. 
Burning pain in the lining of my mouth and throat prevents me from brushing my 
teeth  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
  
Never  
 
 
 
 
 
 
 
 
Always 
 
49. 
I have limitations in the ability to open or move my jaw 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
  
Never  
 
 
 
 
 
 
 
 
Severe 
 
50. 
I have limitations in the ability to move my neck and shoulders  
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
  
Never  
 
 
 
 
 
 
 
 
Severe 
 
 
General Symptom Subscale: 
 
51. 
I have unexplained fatigue  
 

 
Protocol Version #: 13 
 
29 
Protocol Date: 11/28/2017 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
52. 
Fatigue limits my day to day activity  
 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
53. 
I have problems falling asleep 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
54. 
I have problems staying asleep  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
55 
I have episodes of unexplained sweating 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Frequently 
 
56. 
There are times when I am cold and others around me are not  
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
57. 
There are times when I am hot and others around me are not 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
58. 
I have trouble with my memory or processing my thoughts 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
59. 
I have joint pain or muscle aches other than in my neck and shoulders 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
60. 
I feel sad or depressed 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

 
Protocol Version #: 13 
 
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Protocol Date: 11/28/2017 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
61. 
I feel anxious 
 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Never  
 
 
 
 
 
 
 
 
Always 
 
 
 

 
Protocol Version #: 13 
 
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Protocol Date: 11/28/2017 
Appendix C: Pain Diary: 
Date:  
 
Please rate the following on a scale of 0-10 with 0 being no pain and 10 being the worst pain you 
have ever experienced: 
 
1) What is your current pain level? 
 
No Pain 
 
 
 
 
 
 
 
           Worst Pain 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
2) What has been your average pain level this past week? 
 
No Pain 
 
 
 
 
 
 
 
           Worst Pain 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
3) What has been your worst pain level this week? 
 
No Pain 
 
 
 
 
 
 
 
           Worst Pain 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
4) On average, how many breakthrough doses of pain medication have you taken a daily? 
 
 
5) Do you feel that your current pain regiment is appropriately controlling your pain? 
 
 
 
 
 

 
Protocol Version #: 13 
 
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Protocol Date: 11/28/2017 
Appendix D Gabapentin Compliance Diary 
 
 
Date:___ 
 
1. Are you currently taking gabapentin for Pain? 
a. Yes 
b. No 
 
 
IF NO  the patient is not on gabapentin and is no longer required to fill out the remaining 
questions 
 
IF Yes  have redcap prompt the following questions 
 
2.  What is the dosage of each Gabapentin tablet you are prescribed to take? (For example, 
if you are prescribed to take 300 mg tablet 3 times per day, then the dose of each tablet is 
300 mg) 
a. 100 mg 
b. 300 mg 
c. 600 mg 
d. 900 mg 
e. Other, please specify: ___ 
 
3. How often are you prescribed to take your Gabapentin tablet each day? 
a. 1 times/day 
b. 2 times/day 
c. 3 times/day 
d. Other, please specify: ___ 
 
4. Have you missed a dose of your Gabapentin over the last week? 
a. No 
b. Yes 
 
5. If Yes, how many doses have you missed over the last week? (numerical value only) ___ 
 
 
6. For what reason did you miss your dose? 
a. I forgot to take my medicine 
b. I ran out of medicine 
c. I can’t swallow my medicine 
d. Other, please specify ___  
 

 
Protocol Version #: 13 
 
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Protocol Date: 11/28/2017 
Appendix  E: POMS SF PROFILE OF MOOD STATES-
SHORT FORM 
 
Below is a list of words that describe feelings people have. Please read each one carefully. Then 
circle ONE answer to the right which best describes HOW YOU HAVE BEEN FEELING DURING 
THE PAST TWO WEEKS INCLUDING TODAY. 
 
 
 
 
 
 
The numbers refer to these phrases: 
 
 
 
 
0 = not at all 
 
 
 
 
1 = a little 
 
 
 
 
2 = moderately 
 
 
 
 
3 = quite a bit 
 
 
 
 
4 = extremely 
 
 
1.  Tense ..................... 0    1    2    3    4 
20.  Discouraged ........0    1    2    3    4 
2.  Angry .................... 0    1    2    3    4 
21.  Resentful .............0    1    2    3    4 
3.  Worn out............... 0    1    2    3    4 
22.  Nervous ...............0    1    2    3    4 
4.  Unhappy ............... 0    1    2    3    4 
23.  Miserable ............0    1    2    3    4 
5.  Lively..................... 0    1    2    3    4 
24.  Cheerful ..............0    1    2    3    4 
6.  Confused ............... 0    1    2    3    4 
25.  Bitter ....................0    1    2    3    4 
7.  Peeved ................... 0    1    2    3    4 
26.  Exhausted............0    1    2    3    4 
8.  Sad ......................... 0    1    2    3    4 
27.  Anxious................0    1    2    3    4 
9.  Active .................... 0    1    2    3    4 
28.  Helpless ...............0    1    2    3    4 
10. On edge ................ 0    1    2    3    4 
29.  Weary ..................0    1    2    3    4 
11. Grouchy ............... 0    1    2    3    4 
30.  Bewildered ..........0    1    2    3    4 
12. Blue ...................... 0    1    2    3    4 
31.  Furious ................0    1    2    3    4 
13. Energetic .............. 0    1    2    3    4 
32.  Full of pep ...........0    1    2    3    4 
14. Hopeless ............... 0    1    2    3    4 
33.  Worthless ............0    1    2    3    4 
15. Uneasy .................. 0    1    2    3    4 
34.  Forgetful..............0    1    2    3    4 
16. Restless................. 0    1    2    3    4 
35.  Vigorous ..............0    1    2    3    4 
17. Unable to  
 
36.  Uncertain about  
 
concentrate .......... 0    1    2    3    4 
 
things...................0    1    2    3    4 
18. Fatigued ............... 0    1    2    3    4 
37.  Bushed .................0    1    2    3    4 
19. Annoyed ............... 0    1    2    3    4 

 
Protocol Version #: 13 
 
34 
Protocol Date: 11/28/2017 
Appendix F: Neurotoxicity Rating Scale 
Directions: Place an X at the level of severity of each symptom. 
 
Not 
present 
Mild Moderate Severe 
Extremely 
severe 
1. Anxiety 
 
 
 
 
 
2. Health worries 
 
 
 
 
 
3. Sadness/depression 
 
 
 
 
 
4. Restlessness 
 
 
 
 
 
5. No interest in people 
 
 
 
 
 
6. No interest in activities 
 
 
 
 
 
7. Difficulty making 
decisions 
 
 
 
 
 
8. Strange thoughts 
 
 
 
 
 
9. All-over sick feeling 
 
 
 
 
 
10. Difficulty getting to 
sleep 
 
 
 
 
 
11. Diffculty staying 
asleep 
 
 
 
 
 
12. Sleeping too much 
 
 
 
 
 
13. Nausea 
 
 
 
 
 
14. Vomiting 
 
 
 
 
 
15. Loss of appetite 
 
 
 
 
 
16. Tiredness/fatigue 
 
 
 
 
 
17. Distractibility 
 
 
 
 
 
18. Body aches 
 
 
 
 
 
19. Joint pain 
 
 
 
 
 
20. Other pain 
 
 
 
 
 
21. Episodes of confusion 
 
 
 
 
 
22. Word-finding 
problem 
 
 
 
 
 
23. Memory problems 
 
 
 
 
 

 
Protocol Version #: 13 
 
35 
Protocol Date: 11/28/2017 
24. Irritability 
 
 
 
 
 
25. Decreased motivation 
 
 
 
 
 
26. Hallucinations 
 
 
 
 
 
27. Lack of emotion 
 
 
 
 
 
28. Mood swings 
 
 
 
 
 
 
Not 
present 
Mild Moderate Severe 
Extremely 
severe 
29. Tension 
 
 
 
 
 
30. Slowed movements 
 
 
 
 
 
31. Tremor/shakiness 
 
 
 
 
 
32. Walking problems 
 
 
 
 
 
33. Vision problems 
 
 
 
 
 
34. Bowel/blader 
problems 
 
 
 
 
 
35. Loss of interest in sex 
 
 
 
 
 
36. Fever 
 
 
 
 
 
37. Headaches  
 
 
 
 
 
 
 
 
 

 
Protocol Version #: 13 
 
36 
Protocol Date: 11/28/2017 
Appendix G: Quality of Life 
 
Name:_________________________                                 Date:_______________________ 
 
Directions: Please circle the number (0–10) best reflecting your response to the following that 
describes your feelings during the past week, including today. A “0” is as bad as it gets while a 
“10” is a good as it can be.  
 
1.  How would you rate your physical well being over the past week? 
     This question refers to such things as fatigue, activity, etc. 
  
     0 
1 
2 
3 
4 
5 
6 
7 
8 
9
 
10 
     As bad as it can be                                              
 
 
 
     As good 
as it can be 
      
 
 
 
 
 
2.  How would you rate your emotional well being over the past week? 
     This question refers to such things as depression, anxiety, stress, etc. 
    
     0 
1 
2 
3 
4 
5 
6 
7 
8 
9
 
10 
    As bad as it can be                                              
 
 
 
     As good 
as it can be 
      
 
 
 
 
 
 
3.  How would you rate your spiritual well being over the past week? 
     This question refers to such things as a sense of meaning and purpose, relationship with 
     God, etc. 
     
     0 
1 
2 
3 
4 
5 
6 
7 
8 
9
 
10 
    As bad as it can be                                              
 
 
 
     As good 
as it can be 
      
 
 
 
 
 
4.  How would you rate your intellectual well being over the past week? 
     This question refers to such things as the ability to think clearly, to concentrate, to 
     remember, etc. 
      
     0 
1 
2 
3 
4 
5 
6 
7 
8 
9
 
10 
    As bad as it can be                                              
 
 
 
     As good 
as it can be 
      
 
 
 
 
 
5.   How would you rate your overall well being over the past week? 
     
      0 
1 
2 
3 
4 
5 
6 
7 
8 
9      10 

 
Protocol Version #: 13 
 
37 
Protocol Date: 11/28/2017 
  
   As bad as it can be                                              
 
 
 
     As good 
as it can be 
      
 
 
 
 
 
 
 
 
Quality of Life 
Here is a picture of a ladder.  Suppose we say that the top of the ladder shows the best possible 
life for you and the bottom shows the worst possible life for you. 
 
10 
9 
8 
7 
6 
5 
4 
3 
2 
1 
0 
  
Where on the ladder do you feel you personally are now?  Step number  
 
 
 
 
 

 
Protocol Version #: 13 
 
38 
Protocol Date: 11/28/2017 
Appendix H: Disease and Treatment Data Form 
Diagnosis 
 
 
 
 
 
 
 
Date ____/____/_____(mm/dd/year) 
 
 
Type  
(Location/Originating cancerous lesions) 
___(1) Nasal cavity   
___(2) Paranasal sinuses 
___(3) Oral cavity 
___(4) Nasopharynx 
___(5) Oropharynx 
___(6) Hypopharynx  
___(7) Larynx 
___(8) Salivary gland 
___(9) Other______________  
 
Stage: T____N____M____ 
___X 
___0  
___I 
___IIa 
___IIb 
___IIIa 
___IIIb 
___IVa 
___IVb 
___IVc 
 
 
Surgery 
Date____/___/_____ 
Type: 
___(1) Standard RND (radical neck dissection) 
___(2) Bilateral RND 
___(3) Modified RND 
___(4) Modified neck dissection 
___(5) Functional neck dissection 
___(6) Selective neck dissection 
___(7) Other________________  
Number of dissected lymph nodes____ 
Number of positive lymph nodes____ 
 
 
 
 

 
Protocol Version #: 13 
 
39 
Protocol Date: 11/28/2017 
Radiation Therapy 
___None 
___Some 
Site (1) ____________ Dosage______cGy 
Site (2) ____________ Dosage______cGy 
Site (3) ____________ Dosage______cGy 
Site (4) ____________ Dosage______cGy 
Begin date____/____/_____ 
End date  ____/____/_____ 
Pattern of therapy  
 
Days on to days off ratios_______ 
Chemotherapy 
Induction __ Yes___No 
___None 
___some 
Number of cycles____ 
Begin date____/____/_____ 
End date  ____/____/_____ 
Type:  
____(1) Taxol 
____(2) Carboplatin 
(3) Other:_________________________  
 
ChemoXRT 
___None 
___Some 
Begin date____/____/_____ 
End date  ____/____/_____ 
Type:  
____(1) Taxol 
____(2) Carboplatin 
(3) Other:_________________________  
 
Total treatment received 
___ (1) Induction+ ChemoXRT 
___ (2) ChemoXRT 
___ (3) Surgery + ChemoXRT 
___ (4) Surgery + Radiotherapy 
___ (5) Surgery only 
___ (6) Radiotherapy only 
___ (7) other (please list)_________ 
Treatment-related complications_______ 
 
 

 
Protocol Version #: 13 
 
40 
Protocol Date: 11/28/2017 
Appendix I: Study Procedure Calendar 
 
 
 
 
Baseline¥ Week 
1 
Week 
2 
Week 
3 
Week 
4 
Week 
5 
Week 
6 * 
Week 
7 * 
1,2 3 
Months 
post tx 
Study Visit 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Chemoradiation  
Teaching  
X 
 
 
 
 
 
 
 
 
Foundations of 
Oral Care 
X 
 
 
 
 
 
 
 
 
Foundations of 
Pain 
Management 
X 
 
 
 
 
 
 
 
 
Randomization  
X 
 
 
 
 
 
 
 
 
Gabapentin 
Arm 2 Only 
 
X 
X 
X 
X 
X 
X 
X 
X 
Mucositis 
Grading  
 
X 
X 
X 
X 
X 
X 
X 
X 
Demographic 
Survey 
X 
 
 
 
 
 
 
 
 
VHNSS 
Version 2.0 
 
X 
X 
X 
X 
X 
X 
X 
X 
Pain Survey 
 
X 
X 
X 
X 
X 
X 
X 
X 
Compliance 
Survey  
Arm 2 Only 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
Neurotoxicity 
Scale 
X 
 
 
 
 
 
X 
 
X 
(month 
3 only) 
POMS 
X 
 
 
 
 
 
X 
 
X 
(month 
3 only) 
QOL 
X 
 
 
 
 
 
X 
 
X 
(month 
3 only) 
Disease and 
Treatment 
Form 
X 
 
 
 
 
 
 
 
 
 
¥ All baseline assessments must be done within 4 weeks before starting concurrent chemoradiation. 
* Weekly assessments will continue until the completion of chemoradiation which may vary between 5 
and 7 weeks.