Effect of Perioperative Dietary Restriction Strategy on Postoperative Recovery and Outcomes of Patients With Colorectal Cancer : a Multicenter Prospective, Randomized, Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Fudan University
- Enrollment
- 602
- Locations
- 6
- Primary Endpoint
- Disease-free Survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Fasting mimicking diet (Other)
regular diet
regular diet
Outcomes
Primary Outcomes
Disease-free Survival
Time Frame: 3 years
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.
Secondary Outcomes
- Inflammatory factor level(3 years)
- heart rate, blood pressure and basal metabolic rate(3 years)
- body composition(after randomization, before discharge, before and at the completion of each FMD cycle.)
- Weight, height and BMI(3 years)
- upper arm circumference and waistline(3 years)
- plasma protein(3 years)
- Nutritional status(3 years)
- Lymphocyte to Monocyte Ratio (LMR)(3 years)
- Occurrence of clinical complications(3 years)
- Systemic immune-inflammation index (SII)(3 years)
- T Lymphocyte cell count(3 years)
- Feasibility of the FMD in colorectal cancer patients(3 years)
- Quality of life(QOL)(3 years)
- Exercise tolerance(3 years)
- Postoperative pain(3 years)
- Neutrophil to Lymphocyte Ratio (NLR)(3 years)
- insulin-like growth factor-I (IGF-I)(3years)
- insulin(3years)
- Glucose(3years)
- Nutritional status score(Dietary intervention phase (up to 4 months) and 6 months after surgery)
- Quality of life(QOL)(Dietary intervention phase (up to 4 months) and 6 months after surgery)
- Occurrence of clinical complications(within 2 weeks after each chemotherapy cycle)
- fasting serum glucose(4 months)
- fasting insulin(4 months)
- 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)
- Exercise tolerance(Dietary intervention phase (up to 4 months) and 6 months after surgery)
- insulin-like growth factor 1 (IGF-1)(4 months)
- C-peptide(4 months)
Investigators
Changhong Miao
Director
Fudan University