PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HPV-Related Squamous Cell Carcinoma
- Oropharyngeal Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants receiving radiation therapy as part of the OPTIMA II trial (NCT03107182) will be randomized to receive prophylactic gabapentin plus best supportive care versus best supportive care alone.Masking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Enrollment is only available to patients enrolled on the Optima II study (NCT03107182). Primary objective: To compare rates of opioid requirement as a function of supportive care in patients experiencing CTCAE grade ?2 oral mucositis at completion of radiation or chemoradiation as part of OPTIMA II ...
Enrollment is only available to patients enrolled on the Optima II study (NCT03107182). Primary objective: To compare rates of opioid requirement as a function of supportive care in patients experiencing CTCAE grade ?2 oral mucositis at completion of radiation or chemoradiation as part of OPTIMA II Secondary objectives: To compare total opioid equivalent dose above baseline opioid requirement at end of radiation, quality of life metrics, swallowing function, feeding-tube dependence, and protocol compliance in patients managed with best supportive care with or without prophylactic gabapentin. To investigate rates of gabapentin-related toxicity and discontinuation for patients treated on protocol.
Tracking Information
- NCT #
- NCT03423264
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Daniel Haraf, MD University of Chicago
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