NCT03269344已完成3 期
Randomized Phase III, Double-Blind, Placebo Controlled Study of Prophylactic Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up
研究概览
简要总结
Strategies to minimize and mitigate external beam radiation therapy related mucositis and pain during the treatment of head and neck cancer remain limited. The investigators hypothesize that gabapentin could be used to delay or reduce treatment-related pain, reliance on opioid medication, and improve the quality of life for these patients.
详细描述
The specific aims of this proposed study include the following:
- Evaluate the reduction or delay of mucositis related pain and morbidity with the use of gabapentin in patients with stage III or IV oropharyngeal squamous cell carcinoma undergoing definitive radiation with concurrent chemotherapy as part of their cancer management, compared to standard supportive side effect mitigation - using patient reported quality of life endpoints such as the Patient-Reported Oral Mucositis Symptoms (PROMS) scale.
- Assess morphine-equivalent opioid use in both treatment arms by collecting the patient's narcotic use in the previous 24-hour period at each weekly evaluation during radiation treatment.
- Report on change in Speech and swallow performance, as measured by the Performance Status Scale (PSS) for Head and Neck Cancer Patients
- Evaluate changes in weight from baseline throughout treatment between the two arms.
- Assess feeding tube requirements during treatment.
- Evaluate the adverse events associated with gabapentin.
- Evaluate the severity of radiation mucositis (grade 3-4, CTCAE, v. 4)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients being treated with combination chemotherapy and radiation therapy daily for locally advanced (stage III-IV) squamous cell carcinoma of the oropharynx.
- •ECOG performance status ≤
- •Patients must provide study specific informed consent prior to study entry and be able to fill out toxicity and quality of life related questionnaires.
排除标准
- •Patients may not be receiving gabapentin, any other investigational agents, or other anticonvulsants.
- •Patients with metastatic disease are excluded from this clinical trial.
- •Patient with allergies or hypersensitivity to gabapentin.
- •Patients receiving surgery as part of their definitive management.
- •Patients who have received prior chemotherapy or radiation therapy.
- •Patients unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily.
- •Uncontrolled serious illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Control Arm
Placebo Comparator
Standard supportive care during definitive treatment plus placebo
干预措施: Placebo Oral Capsule (Drug)
Experimental Arm
Experimental
Gabapentin plus standard supportive care
干预措施: Gabapentin (Drug)
结局指标
主要结局
Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up
时间窗: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks
Scale tile: Patient Reported Oral Mucositis Symptoms scale, range 0-1000, higher scores indicate worse outcomes
次要结局
- Change in Total FACT-HN Scores From Baseline to Follow-up(Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks)
- Change in PRO-CTCAE Scores From Baseline to Follow-up(Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks)
- Average Opioid Use, Measured in Morphine Equivalents Per Day.(Over the entire study period from baseline to follow-up, approximately 13 weeks)
- Percent Weight Lost(Percent change from baseline to week 7 of treatment)
- Feeding Tube Placement(Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks)
研究者
Andrew Cook
Resident Physcian
Henry Ford Health System
研究点 (1)
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