Effect of FMD on Colorectal Cancer Patients

NCT05384444 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Not applicable

Started

2022-06-08

Last updated

2026-06-12

Condition(s) studied

Fasting Mimicking DietColorectal Cancer

Investigational drug(s) / intervention(s)

Fasting mimicking diet

Fasting mimicking diet: The fasting mimicking diet consists of a 5 day regimen: day 1 diet of the diet supplies \~1000 kcal (10% protein, 56% fat, 34% carbohydrate), day 2-5 are identical in formulation and provide 800 kcal (9% protein, 44% fat, 47% carbohydrate). At least 4 cyclic FMDs will be performed after operation.

Study summary

Extensive preclinical evidence suggests that short-term fasting and fasting mimicking diets (FMDs) can protect healthy cells and render cancer cells more vulnerable to chemotherapy and other therapies. However, fasting is difficult for the old and frail subjects.Therefore, FMDs may be more suitable for postoperative dietary intervention in cancer patients. Colorectal tumors have high glucose consumption, which makes tumor cells very sensitive to changes in nutritional metabolism of the surrounding environment (such as diet restriction / fasting). Previous studies have shown that cyclic FMDs are safe and feasible for cancer patients receiving chemotherapy alone. However, the effects of the FMD in patients under radical surgery for colorectal cancer have not been evaluated so far. This study aims to evaluate the impact of FMDs on postoperative recovery and outcomes of patients with colorectal cancer.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Age 18 \~ 80 years old 2. Patients undergoing radical colorectal cancer resection for the first time 3. Preoperative clinical tumor stage III 4. ASA grade I-III grade 5. With BMI 19-32 kg/m2 6. Adequate liver function, adequate renal function and normal cardiac function 7. Willing to participate in the research of the subject and agree to follow up regularly Exclusion Criteria: 1. Evidence of distant metastasis before surgery 2. Before surgery, have received treatment of neoadjuvant chemotherapy 3. Type 1 diabetes or intensive insulin therapy 4. Allergies for FMD content 5. Combined with severe primary diseases such as severe immune system or autoimmune system or long-term using of glucocorticoids or immunosuppressant 6. History of opioid abuse, mental illness or cognitive impairment

Primary outcome measure(s)

Disease-free Survival — 3 years
DFS is defined as the time from randomisation to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first. The data of participants without an event will be censored at the date of the last follow-up. Follow-up of survival will be conducted at least every 3 months beginning at 6 months after surgery. Postoperative recurrence or metastasis will be determined on the basis of imaging studies, endoscopic examination, or histopathological assessment of biopsy specimens, with a review also performed by an expert panel.

Trial sites (6)

Facility	City	Region
Fudan University Huashan Hospital	Shanghai	Shanghai Municipality
Fudan University Shanghai Cancer center	Shanghai	Shanghai Municipality
Fudan University,ZhongShan Hospital	Shanghai	Shanghai Municipality
Shanghai Changhai Hospital, Naval Medical University,	Shanghai	Shanghai Municipality
Shanghai First People's Hospital,Shanghai Jiaotong University	Shanghai	Shanghai Municipality
Shanghai Tongji Hospital,Tongji University	Shanghai	Shanghai Municipality

More Fudan University trials in China

The Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer Starting soon

Comparing the Efficacy of Sintilimab Plus Nab-POF Regimen, Sintilimab Plus XELOX Chemotherapy, and Lenvatinib, Sintilimab Plus XELOX Chemotherapy in the Treatment of HER2-negative, Metastatic Gastric Cancer Starting soon

an AI-Driven Four-Tier Invasion Depth Classification for Early Esophageal Cancer Active, not recruiting

Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma Starting soon

CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS) Recruiting

Other trials for the same condition

EOCRCPred: an AI Model to Predict Survival in EOCRC Patients After Surgery Starting soon

JAB-21822 Combined With Chemotherapy and Bevacizumab in Second-line KRAS G12C CRC Active, not recruiting

Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC Recruiting

Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease Recruiting

KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05384444 on ClinicalTrials.gov ↗ ← All trials in China