Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07477522

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

Led by West China Hospital · Updated on 2026-03-17

25

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent before any study procedures.
  • Male or female aged 18 to 80 years.
  • Diagnosed with solid tumors confirmed by pathological tissue biopsy.
  • At least one measurable lesion according to RECIST v1.1 criteria (excluding previously treated lesions).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Nutritional Risk Screening (NRS-2002) score less than 3.
  • Body Mass Index (BMI) of 18.5 or higher.
  • Able to eat orally or via feeding tube and tolerate enteral nutrition.
  • Sufficient organ function as indicated by specified laboratory values including neutrophil count, platelets, hemoglobin, serum albumin, bilirubin, liver enzymes, creatinine clearance, coagulation tests, and urine protein.
  • Women of child-bearing potential must agree to use effective contraception from consent until 6 months after last treatment and have a negative serum HCG test within 3 days before treatment, and must not be breastfeeding.
  • If at risk of pregnancy, all participants must use contraception with an annual failure rate below 1% during treatment and for 120 days after last study drug administration (or 180 days after chemotherapy).
Not Eligible

You will not qualify if you...

  • Cognitive impairment or mental illness preventing understanding of the study.
  • Presence of central nervous system or meningeal metastases.
  • Clinically symptomatic moderate or severe ascites requiring paracentesis within 2 weeks before treatment.
  • Uncontrolled or moderate to severe pleural or pericardial effusion.
  • Severe diarrhea, intractable vomiting, malabsorption syndrome, intestinal obstruction, fistulas, gastrointestinal bleeding of CTCAE grade 2 or higher within 3 to 6 months.
  • Known allergy to study drug ingredients or excipients.
  • Poorly controlled diabetes.
  • Poorly controlled hypertension or history of hypertensive crisis or encephalopathy.
  • Severe cardiovascular or cerebrovascular diseases within 6 months prior to enrollment, including unstable angina, heart failure grade II or above, low ejection fraction, or severe arrhythmias.
  • Pregnant or lactating women.
  • Other conditions deemed unsuitable for enrollment by the investigator.

AI-Screening

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Trial Site Locations

Total: 1 location

1

West China Hospital

Chengdu, Sichuan, China

Actively Recruiting

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Research Team

J

Jingwen Wei

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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