NCT03269344

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Conditions

• Oropharynx Cancer

Interventions

Type	Name	Description
DRUG	Gabapentin	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
DRUG	Placebo Oral Capsule	Placebo

Timeline

• Start date: 2017-06-05
• Primary completion: 2020-12-09
• Completion: 2020-12-09
• First posted: 2017-08-31
• Last updated: 2022-01-26
• Results posted: 2022-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study