NCT05384444

Effect of FMD on Colorectal Cancer Patients

Effect of Perioperative Dietary Restriction Strategy on Postoperative Recovery and Outcomes of Patients With Colorectal Cancer : a Multicenter Prospective, Randomized, Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 602 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fasting Mimicking Diet
• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2022-06-08
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2022-05-20
• Last updated: 2024-01-05

Locations

6 sites across 1 country: China