Effect of FMD on Colorectal Cancer Patients

Not Applicable

Recruiting

• Conditions: Colorectal Cancer; Fasting Mimicking Diet
• Interventions: Other: Fasting mimicking diet

• Registration Number: NCT05384444
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-20
• Study Start: 2022-06-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 602

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fasting mimicking diet	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.

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	3 years	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.

Secondary Outcome Measures

Name	Time	Method
heart rate, blood pressure and basal metabolic rate	3 years	heart rate in bpm and blood pressure in mmHg, heart rate and blood pressure will be combined to report basal metabolic rate
body composition	after randomization, before discharge, before and at the completion of each FMD cycle.	Body composition (fat-free mass, fat mass, phase angle, extracellular mass-to-body cell mass ratio (ECM/BCM), total body water and intracellular water, bioelectrical impedance) measurements are analyzed with a Single Frequency Bioimpedance Analyzer (Inbody 770, South Korea).
Inflammatory factor level	3 years	IL-1β,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-17A,IL-17F,TNF-α，TNF-β in pg/ml
Weight, height and BMI	3 years	Weight in kilograms, height in meters, weight and height will be combined to report BMI in kg/m\^2
upper arm circumference and waistline	3 years	upper arm circumference and waistline in centimeters
plasma protein	3 years	plasma protein will be recorded before and at the completion of each FMD cycle.
Nutritional status	3 years	Patient-Generated Subjective Global Assessment (PG-SGA) to measure nutritional status. Higher scores (0-53 scale) indicate a worse nutritional status.
Lymphocyte to Monocyte Ratio (LMR)	3 years	LMR will be measured after randomization, before discharge and before and at the completion of each FMD cycle.
Overall Survival	3 years	OS is defined as the interval between the date of first treatment and the date of death due to any reason.
Occurrence of clinical complications	3 years	Any postoperative complications will be recorded.
Systemic immune-inflammation index (SII)	3 years	SII will be measured after randomization, before discharge and before and at the completion of each FMD cycle.
T Lymphocyte cell count	3 years	T lymphocyte cell count before and at the completion of each FMD cycle.
Feasibility of the FMD in colorectal cancer patients	3 years	Feasibility is defined as the ability of the patient to comply with the prescribed dietary regimen. It will be assessed through the analysis of food diaries filled by patients during the five days of each FMD cycle.
Quality of life(QOL)	3 years	QOL is respectively evaluated by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30). Higher scores (0-100 scale) on the functional scales indicate a better QoL.
Exercise tolerance	3 years	Metabolic Equivalents (METs) scale to measure exercise tolerance. Higher scores (1-10 scale) indicate a better exercise tolerance.
Postoperative pain	3 years	Numerical Rating Scale (NRS) to evaluate pain degree. Higher scores (0-10 scale) indicate a more severe pain.
Neutrophil to Lymphocyte Ratio (NLR)	3 years	NLR will be measured after randomization, before discharge and before and at the completion of each FMD cycle.
insulin-like growth factor-I (IGF-I)	3years	Insulin-like growth factor-I (IGF-I) in ng/ml. IGF-I will be measured before and at the completion of each FMD cycle.
insulin	3years	Insulin in U/L. Insulin will be measured before and at the completion of each FMD cycle.
Glucose	3years	Glucose in mmol/L. Glucose will be measured before and at the completion of each FMD cycle.

Trial Locations

Locations (6)

Shanghai First People's Hospital,Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Changhai Hospital, Naval Medical University,; 🇨🇳 Shanghai, Shanghai, China

Fudan University,ZhongShan Hospital; 🇨🇳 Shanghai, Shanghai, China

Fudan University Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Tongji Hospital,Tongji University; 🇨🇳 Shanghai, Shanghai, China

Fudan University Shanghai Cancer center; 🇨🇳 Shanghai, Shanghai, China