Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy

Study Overview
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Brief Summary
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This randomized phase III trial studies how well gabapentin plus standard of care work compares to standard of care without Gabapentin in preventing inflammation of the mucous membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and neck may cause a burn involving the inside of the mouth, throat, and nasal passages, resulting in pain. Gabapentin may help prevent (or minimize) pain associated with radiation-induced mucositis in patients with head and neck cancer.

Detailed Description
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Primary Objectives: - 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. Secondary Objectives: 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) To correlate pain severity with frequency and severity of general systemic symptoms. Exploratory Objectives: - To determine whether pain control is associated with weight loss (in pounds) and duration of use of percutaneous endoscopic gastrostomy utilization (in days). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Standard of Care (usual care) - Patients receive consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of chemoradiation treatment to review foundations of oral care and pain management. ARM II: Standard of Care plus Gabapentin - Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin orally (PO) three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. After completion of study treatment, patients are followed up monthly for 3 months.

Official Title
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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

Conditions
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Malignant Head and Neck Neoplasm, Mucositis, Radiation-Induced Disorder

Intervention / Treatment
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* Other: Educational Intervention
* Drug: Gabapentin
* Other: Pain Therapy
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Drug: Oxycodone/Acetaminophen
* Drug: Hydrocodone/Acetaminophen
* Drug: Fentanyl
* Drug: Ibuprofen
* Drug: Magic Mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven cancer of the head and neck cancer Stage 3 or 4 Planned primary or adjuvant chemoradiation therapy Willing and able to provide informed consent English speaking Exclusion Criteria: Currently on gabapentin Prior non-tolerance of gabapentin History of seizure disorder

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I Standard of Care<br>Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management. | Other: Educational Intervention<br>* Undergo oral care and pain management education session<br>* Other names: Education for Intervention;Other: Pain Therapy<br>* Receive usual oral health care<br>* Other names: Pain;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Drug: Oxycodone/Acetaminophen<br>* Analgesia<br>* Other names: Percocet;Drug: Hydrocodone/Acetaminophen<br>* Analgesia<br>* Other names: Vicodin;Drug: Fentanyl<br>* Transdermal Analgesia<br>* Other names: Duragesic;Drug: Ibuprofen<br>* NSAID Analgesia<br>* Other names: Advil;Drug: Magic Mouthwash<br>* Oral Solution to treat mucositis<br>* Other names: First-BXN Mouthwash;|
| Experimental: Arm II Standard of Care Plus Gabapentin<br>Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. | Other: Educational Intervention<br>* Undergo oral care and pain management education session<br>* Other names: Education for Intervention;Drug: Gabapentin<br>* Given PO<br>* Other names: 1-(aminomethyl) cyclohexaneacetic Acid, 60142-96-3,;Other: Pain Therapy<br>* Receive usual oral health care<br>* Other names: Pain;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Drug: Oxycodone/Acetaminophen<br>* Analgesia<br>* Other names: Percocet;Drug: Hydrocodone/Acetaminophen<br>* Analgesia<br>* Other names: Vicodin;Drug: Fentanyl<br>* Transdermal Analgesia<br>* Other names: Duragesic;Drug: Ibuprofen<br>* NSAID Analgesia<br>* Other names: Advil;Drug: Magic Mouthwash<br>* Oral Solution to treat mucositis<br>* Other names: First-BXN Mouthwash;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS)) | The pain subscale is composed of 4 items of the Vanderbilt Head and Neck Symptom Survey. The subscale score was calculated by taking the first non-negative principle component of the 4 items. The scale was scores range from 0 to 10 with 10 representing the worst pain. | Up to 3 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0) | Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Frequency distributions will summarize the safety outcome. | Up to 3 months post-treatment | 
| Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form) | Pain severity will be correlated with frequency and severity of general systemic symptoms. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome. The General Symptom Survey is a ten item patient reported outcome measure and outcomes were averaged as there is only one item per symptom category. 0 represented no presence of the symptom with a score of 10 representing the most severe symptom. | Up to 3 months post-treatment |