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Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study

NCT07477522 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-03-17

No results posted yet for this study

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 (≈15-21 g insoluble), whereas Chinese adults consume only \~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.

We therefore propose a study to examine whether a high-insoluble-fibre diet (\>21 g/day) modulates gut-microbiota composition, metabolite profiles and peripheral-blood immune subsets in solid-tumour patients, and to evaluate consequent effects on treatment response and quality of life. The findings will clarify whether fibre-driven microbiota-immune crosstalk can be harnessed as a personalised nutritional strategy to improve cancer outcomes.

Conditions

  • Colorectal Cancer (Diagnosis)
  • Diet Habits
  • High-fibre Diet

Interventions

DIETARY_SUPPLEMENT

High-fibre diet

Dietary fibre, recommended at 25-30 g/d (15-21 g insoluble), is chronically under-consumed (\~11 g/d in China). High-fibre diets increase SCFAs, enhance gut-barrier integrity and boost anti-tumour immunity, correlating with better immunotherapy outcomes in melanoma. Clinical evidence in solid tumours is lacking. Our trial will test whether \>21 g/d insoluble fibre reshapes microbiota, metabolites and immune markers in solid-cancer patients and improves treatment response and quality of life, providing rationale for microbiota-targeted nutrition.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07477522 on ClinicalTrials.gov