PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing
NCT ID: NCT03423264
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2018-01-22
2022-11-08
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Gabapentin
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.
Gabapentin
Gabapentin taken as follows:
Day 1 (evening): 600 mg Day 2 (morning): 600 mg Day 2 (evening): 600 mg Day 3 (morning): 600 mg Day 3 (evening): 900 mg Day 4 (morning): 900 mg Day 4 (evening): 900 mg Day 5 (morning): 900 mg Day 5 (noon): 900 mg Day 5 (evening): 900 mg
Supportive Care Only
Participants will receive standard best supportive care medications as per their treating physician's recommendation.
No interventions assigned to this group
Interventions
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Gabapentin
Gabapentin taken as follows:
Day 1 (evening): 600 mg Day 2 (morning): 600 mg Day 2 (evening): 600 mg Day 3 (morning): 600 mg Day 3 (evening): 900 mg Day 4 (morning): 900 mg Day 4 (evening): 900 mg Day 5 (morning): 900 mg Day 5 (noon): 900 mg Day 5 (evening): 900 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior gabapentin therapy
* Creatinine clearance of \< 45 mL/minute
* Documented intolerance, allergy, or hypersensitivity to gabapentin
* Hemodialysis or peritoneal dialysis
18 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Daniel Haraf, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago Medical Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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IRB17-1550
Identifier Type: -
Identifier Source: org_study_id
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