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

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

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.

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

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

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.

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.

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.

OS is defined as the interval between the date of first treatment and the date of death due to any reason.

heart rate in bpm and blood pressure in mmHg, heart rate and blood pressure will be combined to report basal metabolic rate

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).

Patient-Generated Subjective Global Assessment (PG-SGA) to measure nutritional status. Higher scores (0-53 scale) indicate a worse nutritional status.

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.

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.

Metabolic Equivalents (METs) scale to measure exercise tolerance. Higher scores (1-10 scale) indicate a better exercise tolerance.

Numerical Rating Scale (NRS) to evaluate pain degree. Higher scores (0-10 scale) indicate a more severe pain.

NLR will be measured after randomization, before discharge and before and at the completion of each FMD cycle.

LMR will be measured after randomization, before discharge and before and at the completion of each FMD cycle.

SII will be measured after randomization, before discharge and before and at the completion of each FMD cycle.

Insulin-like growth factor-I (IGF-I) in ng/ml. IGF-I will be measured before and at the completion of each FMD cycle.

Inclusion Criteria: 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 Exclusion Criteria: 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