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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
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
University of Chicago Medical Center
Chicago, Illinois, United States
Rate of opioid use at end of radiation treatment
Comparison of opioid use as part of best supportive care in patients with CTCAE grade ≥ 2 oral mucositis at the end of radiation treatment given as part of OPTIMA II study.
Time frame: 5 days
Total opioid dosage during radiation treatment
Comparison of total opioid dosage given as part of best supportive care in patients with CTCAE grade ≥ 2 oral mucositis at the end of radiation treatment given as part of OPTIMA II study.
Time frame: 5 days
Differences in head and neck symptoms
Measured by changes in patient reported head and neck specific symptoms
Time frame: 24 months
Differences in overall quality of life
Measured by changes in patient reported symptoms
Time frame: 24 months
Differences in chemotherapy-induced peripheral neuropathy symptoms
Measured by patient reported symptoms
Time frame: 24 months
Swallowing Function
1. Normal 2. Within functional limits: abnormal oral or pharyngeal stage but able to eat regular diet; no modifications or swallowing precautions 3. Mild impairment: mild dysfunction in oral or pharyngeal stage, requires modified diet; no therapeutic swallowing precautions 4. Mild-moderate impairment: mild dysfunction in oral and pharyngeal stage, requires modified diet and therapeutic swallowing precautions 5. Moderate impairment: moderate dysfunction in oral or pharyngeal stage, aspiration noted on exam, requires modified diet and swallowing precautions 6. Moderate-severe dysfunction: moderate dysfunction in oral or pharyngeal stage, aspiration noted on exam, requires modified diet and swallowing precautions; requires primary enteral feeding support 7. Severe impairment: severe dysfunction with significant aspiration or inadequate oropharyngeal transit to esophagus, NPO, requires primary enteral feeding support
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Time frame: 12 weeks
Feeding Tube Dependence
Assessment of rates of feeding tube dependence during and after radiation treatment
Time frame: 24 months
Treatment Delays
Determine rate of unplanned radiation treatment delays.
Time frame: 7 weeks
Side Effects
Determine rate of gabapentin related side effects as per CTCAE v4.
Time frame: 13 weeks