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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
65
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
Placebo
Henry Ford Hospital
Detroit, Michigan, United States
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
Time frame: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks
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
Time frame: Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks
Average Opioid Use, Measured in Morphine Equivalents Per Day.
Time frame: 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).
Time frame: 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)
Time frame: 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
Time frame: Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks
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