Effect of FMD on Colorectal Cancer Patients (FCRC22)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Fasting Mimicking Diet
• Intervention / Treatment: Other: Fasting mimicking diet

• Study Type: Interventional
• Enrollment (Estimated): 602
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Huashan Hospital
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University,ZhongShan Hospital
    • Shanghai, Shanghai Municipality, China, 200032
      • Shanghai Changhai Hospital, Naval Medical University,
    • Shanghai, Shanghai Municipality, China, 200032
      • Shanghai First People's Hospital,Shanghai Jiaotong University
    • Shanghai, Shanghai Municipality, China, 200032
      • Shanghai Tongji Hospital,Tongji University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasting mimicking diet; 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; 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.
No Intervention: regular diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	OS is defined as the time from randomisation to death from any cause. The data of participants who are alive at the end of follow-up will be censored at the date of the last follow-up.	3 years
Weight and BMl	Weight will be measured to the nearest 0.1 kg using a calibrated electronic scale. Measurements will be performed in the morning after an overnight fast and voiding, with participants in light clothing and without shoes. Height will be measured to the nearest 1 cm without shoes. BMI is calculated as weight divided by height squared (kg/m²). Measurements will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.	Dietary intervention phase (up to 4 months) and 6 months after surgery
upper arm circumference and waist circumference	Upper arm circumference and waist circumference will be measured to the nearest 0.1 cm using a non-stretchable tape, in the morning after an overnight fast and with the arms abducted to horizontal. Measurements will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.	Dietary intervention phase (up to 4 months) and 6 months after surgery
plasma albumin	Plasma albumin concentration will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in g/L. Measurements will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.	Dietary intervention phase (up to 4 months) and 6 months after surgery
Nutritional status	Nutritional status will be assessed using the Patient-Generated Subjective Global Assessment (PG-SGA) score. Higher scores (0-53 scale) indicate a worse nutritional status. Assessments will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.	Dietary intervention phase (up to 4 months) and 6 months after surgery
Quality of life (QOL)	QoL will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Higher total scores for the level 4 rating items, on a scale of 0-112, indicate a worse QoL. Assessments will be performed before surgery, after surgery, and at months 1, 2, 3, 4 and 6 months.	Dietary intervention phase (up to 4 months) and 6 months after surgery
Exercise tolerance	Exercise tolerance will be assessed using metabolic equivalent of task (MET) values. The MET values will be derived from patient-reported daily physical activities and with reference to the 2011 Compendium of Physical Activities Higher scores (1-23 scale) indicate a better exercise tolerance. Assessments will be conducted before surgery, after surgery, and at months 1, 2, 3, 4 and 6 months.	Dietary intervention phase (up to 4 months) and 6 months after surgery
Chemotherapy-related toxicities	In participants receiving postoperative adjuvant chemotherapy, chemotherapy-related toxicities, including haematological, gastrointestinal, neurological and other adverse events, will be recorded after each chemotherapy cycle and graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).	within 2 weeks after each chemotherapy cycle
insulin-like growth factor 1 (IGF-1)	IGF-1 will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in ng/mL. Measurements will be conducted before surgery, after surgery, and after dietary intervention .	4 months
Fasting serum glucose (FG)	FG will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in mmol/L. Measurements will be conducted before surgery, after surgery, and after dietary intervention.	4 months
Fasting insulin (FI)	FI will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in uU/mL. Measurements will be conducted before surgery, after surgery, and after dietary intervention.	4 months
C-peptide	C-peptide will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in ng/mL. Measurements will be conducted before surgery, after surgery, and after dietary intervention.	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	Safety will be assessed in participants following at least one administration of the FMD regimen. Adverse events occurring during the intervention period will be recorded at each follow-up contact and graded according to CTCAE v5.0. The investigators will assess the severity of each event and its potential relationship with FMD intervention. Safety outcomes will include the frequency and severity of FMD-related adverse events. Predefined FMD-related adverse events include headache, weakness, fatigue, hunger, gastrointestinal symptoms, hypoglycemia, electrolyte abnormalities, and clinically significant weight loss.	Dietary intervention phase (up to 4 months)

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Changhai Hospital; Shanghai Zhongshan Hospital; Huashan Hospital; Tongji Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Cancer Hospital, China
• Investigators: Principal Investigator: Miaomiao Guo, Dr, Shanghai Zhongshan Hospital; Principal Investigator: Meilin Weng, PhD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: B2020-063(2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No