Glutamine for the Prevention of Radiation Toxicity in Subjects Undergoing Breast Conserving Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Excessive Radiation Toxicity as Defined by Radiation Therapy Oncology Group (RTOG) Acute Scale of Radiation-toxicity Criteria
研究概览
简要总结
This study is a single-centered, double-blind, two-arm randomized study to determine if oral glutamine will reduce radiation toxicity for the subjects undergoing Breast Conserving Therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject have been diagnosed with Stage I or II invasive breast cancer
- •Subject will undergo Accelerated Partial Breast Irradiation (APBI) as part of Breast Conserving Therapy (BCT)
- •Subject is eligible for APBI based on American Society of Therapeutic Radiation Oncology (ASTRO) criteria
- •Subject is 18 years of age or older
- •Subject is female
排除标准
- •History of uncontrolled, clinically significant lung, heart, endocrine, liver, or renal disease
- •Subject has been diagnosed with any other cancer
- •Subject has a known hypersensitivity reaction to the following: oral glutamine (GLN), glutamate, monosodium glutamate (MSG) (i.e., Chinese restaurant syndrome)
- •Subject has history of collagen vascular disease
- •Subject has been diagnosed with Diabetes mellitus I or II
- •Subject has had any prior breast radiation
- •Subject is pregnant or breastfeeding
研究组 & 干预措施
Glutamine
Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day
干预措施: Glutamine (Drug)
Placebo
Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day
干预措施: Placebo (Drug)
结局指标
主要结局
Excessive Radiation Toxicity as Defined by Radiation Therapy Oncology Group (RTOG) Acute Scale of Radiation-toxicity Criteria
时间窗: 12 days and 30 days
The primary efficacy outcome will be excessive toxicity, which will be defined as a score of 2 or higher using the Radiation Therapy Oncology Group (RTOG) Acute scale of radiation-toxicity criteria when scored on either the 12-day or 30-day assessment time. The RTOG scale ranges from 0-4 with 0 being defined as "no change".
次要结局
未报告次要终点