HPV-Related Squamous Cell Carcinoma, Oropharyngeal Cancer
Conditions
Keywords
HPV-related oropharyngeal cancer, oropharyngeal cancer, HPV-related squamous cell carcinoma, prophylactic gabapentin, Optima II study
Brief 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.
Detailed 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 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.
Interventions
DRUGGabapentin
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
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of opioid use at end of radiation treatment | 5 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in head and neck symptoms | 24 months | Measured by changes in patient reported head and neck specific symptoms |
| Differences in overall quality of life | 24 months | Measured by changes in patient reported symptoms |
| Differences in chemotherapy-induced peripheral neuropathy symptoms | 24 months | Measured by patient reported symptoms |
| Total opioid dosage during radiation treatment | 5 days | 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. |
| Feeding Tube Dependence | 24 months | Assessment of rates of feeding tube dependence during and after radiation treatment |
| Treatment Delays | 7 weeks | Determine rate of unplanned radiation treatment delays. |
| Side Effects | 13 weeks | Determine rate of gabapentin related side effects as per CTCAE v4. |
| Swallowing Function | 12 weeks | 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 |
Countries
United States
Outcome results
None listed