A Phase 1/2 Study of Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery (The DIET Trial)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in lab values of the dietary intervention on the collagenolytic potential of the microenvironment.
研究概览
简要总结
A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized plant-based low fat/ high-fiber meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Must have histologically or cytologically confirmed colorectal adenocarcinoma.
- •Planned for primary tumor resection at the University of Chicago Medicine ≥21 from date of obtained informed consent. Patients with metastatic disease but undergoing primary site resection are eligible for the study.
- •Age ≥18 years.
- •Patients <18 years of age, children are excluded from this study, because they have unique nutritional requirements that might not be met by with the standardized diet. The food in the diet is designed for adults and would not be feasible for children, especially those attending school. In addition, colon cancer is extremely rare in children.
- •May have received neoadjuvant therapy (chemotherapy, radiation).
- •Patients with Hepatic arterial infusion (HAI) pumps are considered eligible.
- •Ability to understand and willing to sign an informed consent, participate in the dietary intervention, collect stools, donate blood, and complete a pre-nutritional evaluation and compliance/patient satisfaction survey.
排除标准
- •History or current ileostomy or colostomy.
- •Antibiotic exposure within 90 days before diet initiation.
- •Prebiotic exposure within 90 days before diet initiation.
- •Concomitant separate malignancy.
- •Allergy to perioperative medications (oral neomycin/metronidazole for bowel preparation, intraoperative prophylactic intravenous cefazolin and metronidazole).
- •Patients who are pregnant are not eligible for the study.
- •History of inflammatory bowel disease
- •Severe food allergies precluding the ability to tolerate the standardized dietary intervention.
- •Patients with uncontrolled intercurrent illness
- •Pregnant women are excluded from this study because the preoperative diet is not specifically formulated to meet the specific nutritional requirements during the prenatal period
结局指标
主要结局
Change in lab values of the dietary intervention on the collagenolytic potential of the microenvironment.
时间窗: At baseline on Day 1 until final values collected on 6 months post-op visit.
To assess whether the dietary intervention significantly changed the collagenase activity, the site will compare each subject's baseline and final values.
次要结局
- Change in stool samples in the metagenomic response of the gut microbiome to the dietary intervention.(At baseline on Day 1 until final values collected on 6 months post-op visit.)
- Change in the levels of short-chain fatty acids and bile acids in the metabolomic response to the dietary intervention.(At baseline on Day 1 until final values collected on 6 months post-op visit.)
- Change in stool samples of the dietary intervention on components of the urokinase-type plasminogen activator (uPA) plasminogen system.(At baseline on Day 1 until final values collected on 6 months post-op visit.)