A Phase II Randomized Trial of Prophylactic Gabapentin Plus Best Supportive Care Versus Best Supportive Care Alone for Patients Receiving Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Locoregionally-Advanced, HPV-Related Oropharyngeal Cancer: An Optima II Secondary Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of opioid use at end of radiation treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment to OPTIMA II trial (NCT03107182)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Gabapentin (Drug)
结局指标
主要结局
Rate of opioid use at end of radiation treatment
时间窗: 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.
次要结局
- Total opioid dosage during radiation treatment(5 days)
- Differences in head and neck symptoms(24 months)
- Differences in overall quality of life(24 months)
- Differences in chemotherapy-induced peripheral neuropathy symptoms(24 months)
- Swallowing Function(12 weeks)
- Treatment Delays(7 weeks)
- Side Effects(13 weeks)
- Feeding Tube Dependence(24 months)