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Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study
Sponsor: West China Hospital
Summary
Cancer remains a major global public-health challenge and a central focus of medical research. According to the International Agency for Research on Cancer (IARC, 2020), 19.29 million new malignant tumors and 9.96 million cancer deaths occurred worldwide, \>90% being solid cancers. Lung cancer alone accounted for 2.2 million new cases and 1.8 million deaths; \>75% of patients were already at an advanced stage at diagnosis. Current options for late-stage solid tumors are limited: surgery is often impossible because of metastasis; cytotoxic chemotherapy produces dose-limiting toxicities (grade III-IV myelosuppression 15-40%, mucositis 50-80%); radiotherapy risks pneumonitis (5-15%) or enteritis (5-20%) when tumors abut vital organs; targeted agents succumb to acquired resistance after a median 9-13 months; and immune-checkpoint inhibitors achieve \<40% objective response with 7-15% grade 3-4 immune-related adverse events. Dietary intervention is therefore emerging as a promising adjunct. Dietary fibre protects against cardiovascular and metabolic diseases, yet intake is universally low. WHO and the Chinese Nutrition Society recommend 25-30 g total fibre per day (approximately 15-21 g insoluble), whereas Chinese adults consume only approximately 11 g insoluble fibre. High-fibre diets reshape gut microbiota, augment short-chain fatty acid (SCFA) production, strengthen intestinal barrier function, activate CD8⁺ T cells and dampen regulatory T cells, thereby enhancing anti-tumour immunity. A melanoma cohort showed improved progression-free survival under immunotherapy when fibre intake was high. Similar microbiota-immune axes may operate in colorectal and other solid cancers, but clinical data are scarce. This study examines whether supplementation with 16-20 g/day of dietary fibre for 6 weeks modulates gut-microbiota composition, faecal short-chain fatty acid profiles, and peripheral-blood immune-cell subsets in patients with solid tumours. The findings may clarify whether fibre-driven microbiota-immune crosstalk can be harnessed as a personalised nutritional strategy in patients with cancer.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
17
Start Date
2025-12-01
Completion Date
2026-06-30
Last Updated
2026-09-03
Healthy Volunteers
No
Interventions
High-fibre diet
Dietary fibre, recommended at 25-30 g/day (15-21 g/day insoluble fibre), is chronically under-consumed (approximately 11 g/day in China). High-fibre diets increase short-chain fatty acid (SCFA) production, enhance gut-barrier integrity, and boost antitumour immunity, and higher dietary fibre intake has been associated with better immunotherapy outcomes in patients with melanoma. Clinical evidence in patients with solid tumours remains limited. Participants received 16-20 g/day of supplemental dietary fibre for 6 weeks in addition to their usual diet while continuing their prescribed anticancer treatment. The study evaluates whether this dietary intervention is associated with changes in gut microbiota composition, faecal short-chain fatty acid concentrations, and peripheral blood immune-cell subsets.
Locations (2)
Xinjin District Hospital of Traditional Chinese Medicine
Chengdu, Sichuan, China
West China Hospital
Chengdu, Sichuan, China