Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.

Обзор

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.

Вмешательства

• Пищевая добавка Dried chicory roots
  The dried chicory roots are implemented using a dosage of 22.5 gram/day resulting in 18.5 gram additional fibers a day.
• Пищевая добавка Placebo
  The control arm will receive 12.4 grams of placebo a day, isocaloric to the intervention.

Первичные конечные точки

• An increase in the relative abundance of Bifidobacterium in fecal samples. [Срок оценки: From baseline (T0) to 3-4 weeks (T1) after start ICI]

Вторичные конечные точки (5)

• Fecal microbiota composition [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From start intervention at baseline (T0) until the end of wash-out period at 6-7 months (T3) after start ICI.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 2 центра

• Medical Oncology — Nijmegen
• Universitair Medisch Centrum Groningen — Groningen

Идентификаторы

NCT: NCT07686835 · R0007807A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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