NCT03269344

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

Completed Phase 3 Results posted Last updated 26 January 2022

What this trial tests

Phase 3 trial testing Gabapentin in Oropharynx Cancer in 65 participants. Completed in 9 December 2020.

Timeline

5 June 2017

Primary endpoint
9 December 2020

9 December 2020

Quick facts

Lead sponsor	Henry Ford Health System
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	65
Start date	5 June 2017
Primary completion	9 December 2020
Estimated completion	9 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Gabapentin (Gabapentin) — full drug profile →
• Placebo Oral Capsule

Conditions studied

• Oropharynx Cancer — all drugs for Oropharynx Cancer →

Sponsor

Henry Ford Health System — full company profile →

Who can join

18 and older, any sex, with Oropharynx Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up Primary · Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks

Scale tile: Patient Reported Oral Mucositis Symptoms scale, range 0-1000, higher scores indicate worse outcomes

Group	Value	95% CI
Control Arm	20.1	± 16.8
Experimental Arm	29.1	± 22.5

Change in Total FACT-HN Scores From Baseline to Follow-up Secondary · Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks

Scale: Functional Assessment of Cancer Therapy-Trial Outcome (FACT-HN), range 0-148, higher scores indicate better outcomes

Group	Value	95% CI
Control Arm	-15.0	-19.5 – -2.5
Experimental Arm	-20.0	-25.8 – -11.8

Average Opioid Use, Measured in Morphine Equivalents Per Day. Secondary · Over the entire study period from baseline to follow-up, approximately 13 weeks

Group	Value	95% CI
Control Arm	15.6	6.7 – 32.2
Experimental Arm	22.2	13.3 – 35.0

Change in PRO-CTCAE Scores From Baseline to Follow-up Secondary · Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks

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).

Group	Value	95% CI
Control Arm	1.0	-2.0 – 6.0
Experimental Arm	6.5	3.5 – 11.8

Percent Weight Lost Secondary · Percent change from baseline to week 7 of treatment

Percent weight lost from baseline to week 7 of treatment (end of treatment)

Group	Value	95% CI
Control Arm	-10.7	-14.4 – -7.8
Experimental Arm	-11.4	-15.6 – -8.0

Feeding Tube Placement Secondary · Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks

Measure of number of patients who required feeding tube placement at any time during the study period

Group	Value	95% CI
Control Arm	6
Experimental Arm	18

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
   Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4