Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- An increase in the relative abundance of Bifidobacterium in fecal samples.
研究概览
简要总结
Previous research has shown that a higher fiber intake may have a beneficial effect on the intestinal health and improve the effectiveness of immunotherapy, but this is not certain. The objective of this double-blinded randomized clinical trial is to analyze, whether increased dietary fiber intake by patients with metastatic melanoma will increase the relative amount of Bifidobacterium, which in turn stimulates immune cell activity and improves the response to immunotherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically confirmed cutaneous melanoma classified as irresectable stage III or stage IV disease
- •Measurable disease according to RECIST 1.1 criteria
- •Age ≥ 18 years
- •Starting standard-of-care treatment with ICI in first line
- •Written informed consent must be given
- •Able to read and understand Dutch or English
- •Able to comply with study procedures (e.g. willing to provide fecal samples)
排除标准
- •Symptomatic brain metastases
- •Received prior immunotherapy; previous (neo)adjuvant treatment is allowed if the last administration is at least 6 months ago
- •Use of systemic immunosuppressive medications
- •Use of laxatives up to 1 week prior to start of ICI
- •Use of supplements that alter bowel function or gut microbiota such as fibers/prebiotics, probiotics, synbiotics, or postbiotics up to 1 month prior to start of ICI
- •Use of antibiotics up to 1 months prior to start of ICI
- •Use of proton pumps inhibitors (PPI's) up to 3 months prior to start of ICI
- •Pregnant or lactating
- •Current participation in another clinical trial requiring the use of study medication
- •Has a known allergy to plants such as lettuce, sage, tarragon, chicory, artichoke, chamomile, daisy, or sunflower.
- •Has a medical history of gastrointestinal resection (appendectomy is allowed)
- •Has active inflammatory bowel disease
研究组 & 干预措施
Fiber intervention arm
Dried chicory roots
干预措施: Dried chicory roots (Dietary Supplement)
Placebo arm
iso-caloric placebo (rice-puffs)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
An increase in the relative abundance of Bifidobacterium in fecal samples.
时间窗: From baseline (T0) to 3-4 weeks (T1) after start ICI
The primary endpoint of this study is defined as a ≥5% (e.g. from 3% to 8%) increase in the relative abundance of Bifidobacterium in fecal samples between baseline (T0) and follow-up (T1) and significant differences between the experimental arm and the control arm.
次要结局
- Fecal microbiota composition(Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI)
- Radiological response rate to ICI(From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year.)
- Progression free survival (PFS)(From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year.)
- Overall survival (OS)(From baseline (T0) on, survival follow-up will be continued after study completion for a maximal of 5 years in accordance with standard-of-care follow-up.)
- Evaluate the gastro-intestinal side effects of additional dietary fiber intake(From start intervention at baseline (T0) until the end of wash-out period at 6-7 months (T3) after start ICI.)