Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Oropharynx Cancer

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo Oral Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Arm<br>Standard supportive care during definitive treatment plus placebo | Drug: Placebo Oral Capsule<br>* Placebo<br>|
| Experimental: Experimental Arm<br>Gabapentin plus standard supportive care | Drug: Gabapentin<br>* Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up | Scale tile: Patient Reported Oral Mucositis Symptoms scale, range 0-1000, higher scores indicate worse outcomes | Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total FACT-HN Scores From Baseline to Follow-up | Scale: Functional Assessment of Cancer Therapy-Trial Outcome (FACT-HN), range 0-148, higher scores indicate better outcomes | Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks | 
| Average Opioid Use, Measured in Morphine Equivalents Per Day. |  | Over the entire study period from baseline to follow-up, approximately 13 weeks | 
| Change in PRO-CTCAE Scores From Baseline to Follow-up | Scale: Patient-reported outcomes of Common Terminology Criteria for Adverse Events (PRO-CTCAE), 5-point Likert scale, higher scores indicate worse outcomes. Range of scores 0-40 (min-max). | Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks | 
| Percent Weight Lost | Percent weight lost from baseline to week 7 of treatment (end of treatment) | Percent change from baseline to week 7 of treatment | 
| Feeding Tube Placement | Measure of number of patients who required feeding tube placement at any time during the study period | Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks |