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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1) Sign a written informed consent form before any study - related procedures are carried out.

Disqualifiers

(1) Patients with cognitive impairment or mental illness who are unable to understand the study content.

Trial design

Design model

Single group

Treatments tested in this trial

  • High-fibre diet

    Dietary supplement

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: high-insoluble-fibre dietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the safety and tolerability of High-fibre diet in patients with solid tumors.

The occurrence types, frequencies, and severities of treatment - emergent adverse events (TEAE).

Time frame
From enrollment to the end of treatment at 6 weeks

Secondary outcomes

1

Objective Response Rate (ORR)

Evaluate the effectiveness of arginine - restricted diet in patients with solid tumors.

Time frame
From enrollment to the end of treatment at 1 year
2

Disease Control Rate (DCR)

Evaluate the effectiveness of arginine - restricted diet in patients with solid tumors.

Time frame
From enrollment to the end of treatment at 1 year
3

Duration of Response (DoR)

Evaluate the effectiveness of arginine - restricted diet in patients with solid tumors

Time frame
From enrollment to the end of treatment at 1 year

Other outcomes

Sponsors and contacts

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