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Effect of plant-based dietary intervention on FOLFOX chemotherapy-induced gastrointestinal toxicity and intestinal microecology in colorectal cancer patients

Effect of plant-based dietary intervention on FOLFOX chemotherapy-induced gastrointestinal toxicity and intestinal microecology in colorectal cancer patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095215
Enrollment
Unknown
Registered
2025-01-03
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

intervention group:Plant-based diet
Control group A:Regular diets
Control group B:Regular Diets + Whole Nutrients Tumor Formula

Sponsors

West China School of Public Health and West China Fourth Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients must meet the clinical or (and) pathologic diagnostic criteria for colorectal cancer. 2. 65 years >= age >= 18 years. 3. FOLFOX chemotherapy regimen, expected chemotherapy > 2 months 4. Subjective consciousness, able to communicate normally 5. Able to eat orally 6. No other medication has been added in the last month; 7. Health status: BMI 20 - 35 kg/m^2 , KPS score >= 60; not suffering from any underlying diseases such as hypertension, diabetes, etc; 8. Not taking any medication for a long period of time, daily alcohol consumption <= 50g/day; 9. Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are participating in other studies 2. Dietary contraindications include vegetarian diets, plant food components and food allergies or other problems preventing intake of the study diet. 3. Taking antibiotics, probiotics, multivitamins and supplements (fish oil or n-3 fatty acids and herbal supplements, calcium, vitamin D supplements) 30 days prior to the study. Non-steroidal anti-inflammatory drugs (NSAIDs) or antihistamines, or inability to discontinue the use of these substances between 72 hours prior to the first day of blood draw and 48 hours after receipt of the delayed-type hypersensitivity (DTH) skin test implant, and use of immunosuppressive drugs. 4. Smoking > 20 cigarettes per day; drinking > 2 ml cups of alcohol or not willing to abstain from alcohol for the duration of the study. 5. Excluded health conditions include: diagnosed major uncontrolled diseases such as autoimmune diseases, hematologic diseases, cardiovascular diseases, and infections. Patients with combined cerebral infarction, limb loss, post pacemaker implantation, etc. who are unable to perform body composition testing; patients with combined heart failure, shock, and severe edema; 6. Patients with combined intellectual, cognitive, and hearing abnormalities will be excluded;

Design outcomes

Primary

MeasureTime frame
Gastrointestinal Toxicity Reaction Grading;Serum inflammatory biomarker levels;Gut microecology (gut bacteria abundance, species, metabolites);

Secondary

MeasureTime frame
Biochemical and metabolic indicators;Immunity indicators;Tumor markers of colorectal cancer;nutritional status;Fatigue;anxiety and depression;Quality of life;

Countries

China

Contacts

Public ContactWei Peng

West China School of Public Health and West China Fourth Hospital, Sichuan University

hxnyyyg@163.com+86 159 2859 2228

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 4, 2026