A Randomized Placebo-controlled Feasibility Trial of Probiotic Supplementation During Adjuvant or Neoadjuvant Cytotoxic Chemotherapy for Solid Tumor Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Number of Participants at end of study
研究概览
简要总结
This is a pilot single-blind placebo-controlled randomized trial to establish experimental feasibility. We plan on enrolling a pilot cohort of 40 patients, with up to 5 patients in treatment phase 0 and the remaining in treatment phase I. During Phase I, the remaining participants will be assigned to either treatment or control group using dynamic block randomization balancing on sex, age group, and disease histology.
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
- 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
- •Adults ≥18 years old
- •Diagnosis of stage III colon cancer
- •Undergoing chemotherapeutic treatment within the MHFV or MVAHC medical systems.
排除标准
- •Allergy or sensitivity to probiotic supplementation
- •Diagnosis/history of:
- •Non-colon GI cancer or chronic GI-related disease or disorders such as gastric ulcer, irritable bowel syndrome, inflammatory bowel disease, or intestinal malabsorption syndrome Cognitive impairment, such as dementia, or developmental disorder that would affect ability to give consent or comply with study procedures
- •Current treatment of cancer other than non-melanoma skin cancer, including metastases and recurrences
- •Current participation in another interventional study of medication(s)
- •Major changes in eating habits within the past 3 months, such as stopping or starting a restricted diet
- •BMI ≥40 kg/m2 or ≤17 kg/m2
- •Unexpected change in weight of ˃4.5 kg within the past 6 months
研究组 & 干预措施
Phase 0: Placebo
The placebo will also be manufactured and provided by the commercial provider.
干预措施: Placebo (Other)
Phase 1: Placebo
Placebo capsules of the same size and shape to be taken daily for 12 weeks. The placebo will also be manufactured and provided by the commercial provider.
干预措施: Placebo (Other)
Phase 1: Treatment
50 billion CFU of a commercially available Lactobacillus and Bifidobacterium oral capsule, to be taken daily for 12 weeks
干预措施: Lactobacillus and Bifidobacterium (Biological)
结局指标
主要结局
Number of Participants at end of study
时间窗: Week 12
Determine the feasibility of conducting a randomized, placebo controlled clinical trial of probiotic supplementation in patients with solid tumor malignancies undergoing cytotoxic chemotherapeutic treatment. Number of participants that completed the study.
次要结局
- Number of Adverse Events related to Cytotoxic Chemotherapy(Week 12)