Clinical trial NCT03269344: Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer
Official title: Randomized Phase III, Double-Blind, Placebo Controlled Study of Prophylactic Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oropharynx Cancer
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Strategies to minimize and mitigate external beam radiation therapy related mucositis and pain during the treatment of head and neck cancer remain limited. The investigators hypothesize that gabapentin could be used to delay or reduce treatment-related pain, reliance on opioid medication, and improve the quality of life for these patients.

Detailed description: The specific aims of this proposed study include the following:

* Evaluate the reduction or delay of mucositis related pain and morbidity with the use of gabapentin in patients with stage III or IV oropharyngeal squamous cell carcinoma undergoing definitive radiation with concurrent chemotherapy as part of their cancer management, compared to standard supportive side effect mitigation - using patient reported quality of life endpoints such as the Patient-Reported Oral Mucositis Symptoms (PROMS) scale.
* Assess morphine-equivalent opioid use in both treatment arms by collecting the patient's narcotic use in the previous 24-hour period at each weekly evaluation during radiation treatment.
* Report on change in Speech and swallow performance, as measured by the Performance Status Scale (PSS) for Head and Neck Cancer Patients
* Evaluate changes in weight from baseline throughout treatment between the two arms.
* Assess feeding tube requirements during treatment.
* Evaluate the adverse events associated with gabapentin.
* Evaluate the severity of radiation mucositis (grade 3-4, CTCAE, v. 4)

Eligibility criteria: Inclusion Criteria:

* Patients being treated with combination chemotherapy and radiation therapy daily for locally advanced (stage III-IV) squamous cell carcinoma of the oropharynx.
* Age ≥ 18.
* ECOG performance status ≤ 1.
* Patients must provide study specific informed consent prior to study entry and be able to fill out toxicity and quality of life related questionnaires.

Exclusion Criteria:

* Patients may not be receiving gabapentin, any other investigational agents, or other anticonvulsants.
* Patients with metastatic disease are excluded from this clinical trial.
* Patient with allergies or hypersensitivity to gabapentin.
* Patients receiving surgery as part of their definitive management.
* Patients who have received prior chemotherapy or radiation therapy.
* Patients unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily.
* Uncontrolled serious illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up
timeFrame: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks
Secondary outcomes:
measure: Change in Total FACT-HN Scores From Baseline to Follow-up
timeFrame: Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks
measure: Average Opioid Use, Measured in Morphine Equivalents Per Day.
timeFrame: Over the entire study period from baseline to follow-up, approximately 13 weeks
measure: Change in PRO-CTCAE Scores From Baseline to Follow-up
timeFrame: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks
measure: Percent Weight Lost
timeFrame: Percent change from baseline to week 7 of treatment
measure: Feeding Tube Placement
timeFrame: Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Farzan Siddiqui, MD PhD
role: STUDY_CHAIR
References:
citation: Cook A, Modh A, Ali H, Sheqwara J, Chang S, Ghanem T, Momin S, Wu V, Tam S, Money S, Han X, Fakhoury L, Movsas B, Siddiqui F. Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Prophylactic Gabapentin for the Reduction of Oral Mucositis Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma. Int J Radiat Oncol Biol Phys. 2022 Mar 15;112(4):926-937. doi: 10.1016/j.ijrobp.2021.11.012. Epub 2021 Nov 20.