PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing
Oropharyngeal Cancer, HPV-Related Squamous Cell Carcinoma
About this trial
This is an interventional supportive care trial for Oropharyngeal Cancer focused on measuring HPV-related oropharyngeal cancer, oropharyngeal cancer, HPV-related squamous cell carcinoma, prophylactic gabapentin, Optima II study
Eligibility 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
Sites / Locations
- University of Chicago Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Gabapentin
Supportive Care Only
Participants randomized to this arm will receive gabapentin beginning on evening of the first day of radiation treatment at a dose of 600 mg. Gabapentin will continue to be taken twice a day (morning and evening) for the next 4 days of radiation treatment at increasing doses (up to 900 mg). Participants will continue to receive standard best supportive care medications as per their treating physician's recommendation.
Participants will receive standard best supportive care medications as per their treating physician's recommendation.