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

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.

Timeline

Start

2017-06-05

Primary completion

2020-12-09

Completion

2020-12-09

Outcome

Missed primary endpoint

paper No significant difference was found in PROMS scores PMID 34808255 ↗

registry analysis (superiority test); Control Arm vs Experimental Arm; p = 0.11; ANOVA NCT03269344 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gabapentin	Unknown	600 mg	—

Indications