S9908, A Double-Blind, Placebo-Controlled Trial To Study The Efficacy And Safety Of L-Glutamine (In AES0014 Delivery Vehicle) Upon Radiation Therapy-Induced Oral Mucositis In Head and Neck Cancer Patients, Phase III
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 107
- 主要终点
- Effectiveness of L-glutamine for mucositis
研究概览
简要总结
RATIONALE: Glutamine may be effective in decreasing side effects, such as inflammation of the mouth and throat, caused by radiation therapy. The effectiveness of glutamine for mucositis is not yet known.
PURPOSE: Randomized phase III trial to determine the effectiveness of glutamine in treating patients who develop mucositis following radiation therapy for newly diagnosed cancer of the mouth or throat.
详细描述
OBJECTIVES:
- Compare the efficacy of L-glutamine vs placebo, in terms of maximum mucositis toxic effects and worst reported mouth pain during and after high-dose radiotherapy, in patients with newly diagnosed, previously untreated squamous cell cancer of the oral cavity or oropharynx.
- Compare the duration of severe mucositis in patients treated with these regimens.
- Compare the radiotherapy delay in patients treated with these regimens.
- Compare weight loss in patients treated with these regimens.
- Compare the toxic effects of these two regimens in these patients.
- Compare patient-reported mouth pain success rate in patients treated with these regimens.
- Determine the compliance of patients treated with this drug regimen.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to concurrent cisplatin or carboplatin (yes vs no), concurrent fluorouracil (yes vs no), and presence of feeding tube (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning 4 to 7 days prior to radiotherapy, patients receive oral L-glutamine 3 times daily for 60-80 days. Patients receive concurrent high-dose radiotherapy for approximately 6 weeks.
- Arm II: Patients receive oral placebo and high-dose radiotherapy as in arm I. In both arms, treatment continues in the absence of unacceptable toxicity.
Patients are followed for 2 weeks.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
L-glutamine in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.
干预措施: glutamine (Dietary Supplement)
L-glutamine in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.
干预措施: radiation therapy (Radiation)
Placebo in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.
干预措施: radiation therapy (Radiation)
Placebo in suspension + radiation
20 cc three times daily for 60 days plus radiation therapy.
干预措施: l-glutamine placebo (Drug)
结局指标
主要结局
Effectiveness of L-glutamine for mucositis
时间窗: 2 weeks after end of radiation treatment
Evaluate effectiveness of L-glutamine as compared to placebo in terms of: maximum toxicity grade during radiation treatment, mucositis toxicity grade 2 weeks after the end of radiation treatment, and patient reported worst mouth pain two weeks after the end of radiation treatment.
次要结局
- Duration of severe mucositis, radiation treatment delay, and weight loss(2 weeks after radiation treatment)
- Toxicities(within 2 weeks after radiation treatment)
- Compare patient reported mouth pain "success" rate at the end of radiation treatment(2 weeks after end of radiation treatment)
- Compliance (dose taken) in patients treated with L-glutamine when given with radiation treatment(2 weeks after end of radiation treatment)