Randomized, Double Blinded Placebo-Controlled Study of Glutamine in Patients With Oral Mucositis on an mTOR Inhibitor-based Regimen or Esophagitis on a Regimen Receiving Radiation to the Esophagus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Severity of Esophagitis for Radiation Therapy Patients
研究概览
简要总结
The goal of this clinical research study is to learn if glutamine can help control and prevent sores, blisters, or inflammation in your mouth or esophagus due to your current treatment.
In this study, glutamine will be compared to a placebo. A placebo is not a drug. It looks like the drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:
- If you are in Group 1, you will receive glutamine.
- If you are in Group 2, you will receive a placebo.
Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug Administration:
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, Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will be initiating therapy with any investigator-initiated mTOR inhibitor based therapy in the Department of Investigational Cancer Therapeutics (Phase I Program) or initiating radiation therapy to the esophagus.
- •For the esophagitis arm, any patient with thoracic malignancies, which will receive radiation alone or concurrent chemo/radiation. Radiation dose must be >/= 45 Gy. For the esophagitis arm, induction chemotherapy is allowed.
- •Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
- •Patients must be >/= 17 years of age.
- •Females of childbearing potential must have a negative pregnancy test. Sexually active patients must agree to use contraception prior to, during, and 30 days after last dose.
排除标准
- •Patients currently receiving therapy for mucositis.
研究组 & 干预措施
mTOR Inhibitor Patient Group - Placebo
Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.
干预措施: Placebo (Other)
mTOR Inhibitor Patient Group - Placebo
Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.
干预措施: Questionnaires (Behavioral)
mTOR Inhibitor Patient Group - Glutamine
Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.
干预措施: Glutamine (Drug)
mTOR Inhibitor Patient Group - Glutamine
Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.
干预措施: Questionnaires (Behavioral)
Radiation Therapy to Esophagus Patient Group - Placebo
Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.
干预措施: Placebo (Other)
Radiation Therapy to Esophagus Patient Group - Placebo
Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.
干预措施: Questionnaires (Behavioral)
Radiation Therapy to Esophagus Patient Group - Glutamine
Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.
干预措施: Glutamine (Drug)
Radiation Therapy to Esophagus Patient Group - Glutamine
Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Severity of Esophagitis for Radiation Therapy Patients
时间窗: 6 weeks
For esophagus radiation participants, the severity of esophagitis will be taken as the highest grade observed by week six. Wilcoxon rank sum test used to compare the ordered categories of esophagitis severity.
Severity of Oral Mucositis for mTOR Inhibitor Patients
时间窗: 6 months after start of mTOR inhibitor based treatment
For mTOR inhibitor patients, the severity of oral mucositis will be taken as the maximum grade observed during the 6-month study period. Wilcoxon rank sum test used to compare the ordered categories of mucositis severity.
次要结局
- Summary of Adverse Events by Grade and Relationship - Radiation Cohort(weekly during radiation, 1 month and 6 months post radiation therapy until resolution, stabilization, death, loss to follow up, or commencement of new therapy)
- Duration of Esophagitis After Radiation Treatment Start(From event starts to end of study visit)
- Grade 3 or Higher Mucositis Incidence Per Participant During 6 Months After Treatment Start(6 month)
- Proportion of Participants Who Were Mucositis-Free at 18.3 Weeks(18.3 weeks)
- Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline(at baseline)
- Mucositis Incidence Per Participant During 6 Months After mTOR Inhibitor Treatment Start(6 months)
- Time to Esophagitis on the Radiation Cohort Onset(From radiation starts to end of study visit)
- Number of Participants With Esophagitis During 6 Weeks After Radiation Treatment Start(6 weeks)
- Radiation Cohort Participant Weight Change From Baseline to End of Study(from baseline to 6 months post radiation therapy)
- Duration of Mucositis After mTOR Inhibitor Treatment Start(From event starts to end of study visit)
- mTOR Inhibitor Cohort Participant Weight Change From Baseline to End of Study(baseline, weekly during Cycle 1, and Day 1 of Cycle 2 and beyond, and 4 weeks and 6 months after the last dose of the mTOR inhibitor)
- Quality of Life (QOL) in Esophagus Radiation Patients at Baseline(at baseline)
- Grade 3 or Higher Esophagitis Incidence Per Participant During 6 Weeks After Radiation Start(6 weeks)
- Number of Participants With Cancer Treatment Interruptions Due to Esophagitis(From radiation treatment start to end of study visit, approximately 6 months)
- Number of Participants With Cancer Treatment Interruptions Due to Mucositis(6 months after start of mTOR inhibitor based treatment)
- Summary of Adverse Events by Grade and Relationship - mTOR Inhibitor Cohort(weekly during Cycle 1, and Day 1 of Cycle 2 and beyond, and 4 weeks and 6 months after the last dose of the mTOR inhibitor until resolution, stabilization, death, loss to follow up, or commencement of new therapy)