Overview

PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing

Status:
Recruiting

Trial end date:
2023-06-01

Target enrollment:
0

Participant gender:
All

Summary

Enrollment is only available to patients enrolled on the Optima II study (NCT03107182). The purpose of this trial is to compare rates of opioid use at completion of radiation for patients with Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 oral mucositis after receiving definitive nonoperative locoregional therapy with or without prophylactic gabapentin as part of best supportive care for locoregionally-advanced, HPV-related oropharyngeal cancer. Secondary purposes include comparison of total equivalent opioid dosage above baseline opioid use at end of treatment, quality of life metrics, swallowing function, feeding tube dependence, and protocol compliance in patients managed with best support care with or without prophylactic gabapentin. Rates of gabapentin-related side effects and discontinuation will also be investigated.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Chicago

Treatments:

Gabapentin
gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

- Enrollment to OPTIMA II trial (NCT03107182)

Exclusion Criteria:

- Ineligible for enrollment to OPTIMA II trial (NCT03107182)

- Prior gabapentin therapy

- Creatinine clearance of < 45 mL/minute

- Documented intolerance, allergy, or hypersensitivity to gabapentin

- Hemodialysis or peritoneal dialysis