Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gabapentin | Drug | — | UNRESOLVED |
| Placebo Oral Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control Arm
- description
- Standard supportive care during definitive treatment plus placebo
- interventionNames
- Drug: Placebo Oral Capsule
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- Gabapentin plus standard supportive care
- interventionNames
- Drug: Gabapentin
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCook 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. PMID 34808255