PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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.