Effect of FMD on Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

— FCRC22  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384444
• Other study ID #: B2020-063(2)
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: October 30, 2025

Study information

• Verified date: January 2024
• Source: Fudan University
• Contact: Changhong Miao, PhD
• Phone: +8613621756315
• Email: miaochh[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 602
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Fasting Mimicking Diet

Intervention

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.

Locations

Country	Name	City	State
China	Fudan University Huashan Hospital	Shanghai	Shanghai
China	Fudan University Shanghai Cancer center	Shanghai	Shanghai
China	Fudan University,ZhongShan Hospital	Shanghai	Shanghai
China	Shanghai Changhai Hospital, Naval Medical University,	Shanghai	Shanghai
China	Shanghai First People's Hospital,Shanghai Jiaotong University	Shanghai	Shanghai
China	Shanghai Tongji Hospital,Tongji University	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Fudan University	Changhai Hospital, Huashan Hospital, Shanghai Cancer Hospital, China, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival	OS is defined as the interval between the date of first treatment and the date of death due to any reason.	3 years
Secondary	Weight, height and BMI	Weight in kilograms, height in meters, weight and height will be combined to report BMI in kg/m^2	3 years
Secondary	upper arm circumference and waistline	upper arm circumference and waistline in centimeters	3 years
Secondary	heart rate, blood pressure and basal metabolic rate	heart rate in bpm and blood pressure in mmHg, heart rate and blood pressure will be combined to report basal metabolic rate	3 years
Secondary	body composition	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).	after randomization, before discharge, before and at the completion of each FMD cycle.
Secondary	plasma protein	plasma protein will be recorded before and at the completion of each FMD cycle.	3 years
Secondary	Nutritional status	Patient-Generated Subjective Global Assessment (PG-SGA) to measure nutritional status. Higher scores (0-53 scale) indicate a worse nutritional status.	3 years
Secondary	Feasibility of the FMD in colorectal cancer patients	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.	3 years
Secondary	Quality of life(QOL)	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.	3 years
Secondary	Exercise tolerance	Metabolic Equivalents (METs) scale to measure exercise tolerance. Higher scores (1-10 scale) indicate a better exercise tolerance.	3 years
Secondary	Postoperative pain	Numerical Rating Scale (NRS) to evaluate pain degree. Higher scores (0-10 scale) indicate a more severe pain.	3 years
Secondary	Occurrence of clinical complications	Any postoperative complications will be recorded.	3 years
Secondary	Neutrophil to Lymphocyte Ratio (NLR)	NLR will be measured after randomization, before discharge and before and at the completion of each FMD cycle.	3 years
Secondary	Lymphocyte to Monocyte Ratio (LMR)	LMR will be measured after randomization, before discharge and before and at the completion of each FMD cycle.	3 years
Secondary	Systemic immune-inflammation index (SII)	SII will be measured after randomization, before discharge and before and at the completion of each FMD cycle.	3 years
Secondary	Inflammatory factor level	IL-1ß,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-17A,IL-17F,TNF-a,TNF-ß in pg/ml	3 years
Secondary	T Lymphocyte cell count	T lymphocyte cell count before and at the completion of each FMD cycle.	3 years
Secondary	insulin-like growth factor-I (IGF-I)	Insulin-like growth factor-I (IGF-I) in ng/ml. IGF-I will be measured before and at the completion of each FMD cycle.	3years
Secondary	Glucose	Glucose in mmol/L. Glucose will be measured before and at the completion of each FMD cycle.	3years
Secondary	insulin	Insulin in U/L. Insulin will be measured before and at the completion of each FMD cycle.	3years