Effect of FMD on Colorectal Cancer Patients

NCT05384444 | Active Not Recruiting DMC

• 1 other identifier: B2020-063(2)
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

  DFS is defined as the interval between the date of first treatment and the date of recurrence or metastasis or secondary primary tumor or death.

  3 years

Secondary Outcomes (12)

• Overall Survival

  3 years

• Weight and BMl

  Dietary intervention phase (up to 4 months) and 6 months after surgery

• upper arm circumference and waist circumference

  Dietary intervention phase (up to 4 months) and 6 months after surgery

• plasma albumin

  Dietary intervention phase (up to 4 months) and 6 months after surgery

• Nutritional status score

  Dietary intervention phase (up to 4 months) and 6 months after surgery

Other Outcomes (1)

• Safety outcome

  Dietary intervention phase (up to 4 months)

Study Arms (2)

Fasting mimicking diet

EXPERIMENTAL

The cyclic FMD 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.

Other: Fasting mimicking diet

regular diet

NO INTERVENTION

regular diet

Interventions

Fasting mimicking diet OTHER

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.

Fasting mimicking diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 \~ 80 years old
• Patients undergoing radical colorectal cancer resection for the first time
• Preoperative clinical tumor stage III
• ASA grade I-III grade
• With BMI 19-32 kg/m2
• Adequate liver function, adequate renal function and normal cardiac function
• Willing to participate in the research of the subject and agree to follow up regularly

You may not qualify if:

• Evidence of distant metastasis before surgery
• Before surgery, have received treatment of neoadjuvant chemotherapy
• Type 1 diabetes or intensive insulin therapy
• Allergies for FMD content
• Combined with severe primary diseases such as severe immune system or autoimmune system or long-term using of glucocorticoids or immunosuppressant
• History of opioid abuse, mental illness or cognitive impairment

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Cancer Hospital, China: collaborator
• Huashan Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Tongji Hospital: collaborator
• Changhai Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator

Study Sites (6)

Fudan University Huashan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Fudan University Shanghai Cancer center

Shanghai, Shanghai Municipality, 200032, China

Location

Fudan University,ZhongShan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Changhai Hospital, Naval Medical University,

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai First People's Hospital,Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Tongji Hospital,Tongji University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Miaomiao Guo, Dr

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Meilin Weng, PhD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Allocation concealment：an independent researcher implements the randomized allocation scheme to ensure that the subjects and the researchers who screen the subjects are unable to know the subsequent subjects in advance
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Concealed allocation: the statisticians formulate the randomization scheme and generates the random number.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: May 20, 2022
• Study Start: June 8, 2022
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)