A Pilot Study Examining Dietary Restriction of Sulfur Containing Amino Acids by Cysteine and Methionine Deprivation (CMD) in Glioma Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in systemic glutathione metabolites
研究概览
简要总结
This pilot study looks at how certain diet changes affect the body in patients with recurrent brain tumors (glioma) who are planning to have standard treatment like radiation or surgery. Up to 30 patients will be randomly assigned to either a regular diet or a special diet that limits two nutrients (cysteine and methionine) for 2, 4, or 7 days before their treatment.
Patients will be monitored for side effects using blood tests and questionnaires, and patients will keep a diary to track how well they follow the diet. Blood and urine samples will be used to see how the diet affects the body. Tumor samples (from surgery) will help researchers study how the cancer cells behave, and stool samples will be used to look at gut bacteria.
This is a randomized, blinded interventional pilot study to measure glutathione metabolite levels with a cysteine/methionine deprivation (CMD) diet in glioma patients. A menu of pre-prepared meals will be provided to subjects that consist of either a control diet or a CMD diet. The CMD diet will be implemented simultaneously in 2 cohorts of participants with recurrent glioma.
The primary objective will be to measure the metabolic state of glioblastome multiforme tumor cells through dietary restriction of the sulfur-containing amino acids (SAA), cysteine/cystine and methionine.
Patient from cohort A can later be included in Cohort B if applicable. Patients will be followed for progression free survival and overall survival for up to 1 year, or until they discontinue or are removed from the study for exploratory endpoints.
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
- Single (Participant)
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
- •In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up until the point at which the subject receives treatment for the subject to be considered eligible for treatment.
- •Inclusion Criteria:
- •Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- •Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
- •Age ≥ 18 years at the time of consent.
- •Karnofsky Performance Status of ≥ 60 assessed at diagnosis
排除标准
- •Active infection requiring systemic therapy.
- •Any active disease that may be associated with unacceptable anesthetic/operative risk.
- •Pregnant or breastfeeding
- •Subjects with prior brain metastasis.
- •Transfusion within 7 days of diet initiation
研究组 & 干预措施
Cohort B: Radiation Therapy Control
Participants will undergo radiation therapy and receive a normal diet.
干预措施: Normal diet (Other)
Cohort B: Radiation Therapy 2 days
Participants will undergo radiation therapy and receive a a cysteine/methionine deprivation (CMD) diet for 2 days.
干预措施: Cysteine/methionine deprivation (CMD) diet for 2 days (Other)
Cohort B: Radiation Therapy 4 days
Participants will undergo radiation therapy and receive a a cysteine/methionine deprivation (CMD) diet for 4 days.
干预措施: Cysteine/methionine deprivation (CMD) diet for 4 days (Other)
Cohort A: Surgery Diet Restriction 2 days
Participants will undergo surgery and receive a cysteine/methionine deprivation (CMD) diet for 2 days.
干预措施: Cysteine/methionine deprivation (CMD) diet for 2 days (Other)
Cohort A: Surgery Control
Participants will undergo surgery and receive a normal diet.
干预措施: Normal diet (Other)
Cohort A: Surgery Diet Restriction 4 days
Participants will undergo surgery and receive a cysteine/methionine deprivation (CMD) diet for 4 days.
干预措施: Cysteine/methionine deprivation (CMD) diet for 4 days (Other)
结局指标
主要结局
Change in systemic glutathione metabolites
时间窗: Baseline and up to 4 days
Systemic glutathione metabolite levels in blood and urine will be assessed before and after a 2-day randomized assigned diet (normal or Cysteine and methionine deprivation (CMD)) diet. Measurements will be obtained using laboratory assays and Magnetic resonance (MR) spectroscopy. Analyses will be conducted overall and stratified by patients scheduled for standard-of-care (SOC) radiation therapy or surgery.
次要结局
- Change in systemic glutathione metabolites(Baseline and up to 6 days)
- Change in tumor tissue glutathione metabolites(At time of surgical resection and up to 6 days)
- Compliance with assigned diet regimen(Baseline and up to 6 days.)
- Safety of normal or Cysteine and methionine deprivation diet(Up to 30 days)
- Progression-Free Survival (PFS)(1 year)
- Overall Survival(1 year)