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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
602
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.
Fudan University Huashan Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, China
Fudan University,ZhongShan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital, Naval Medical University,
Shanghai, Shanghai Municipality, China
Shanghai First People's Hospital,Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Shanghai Tongji Hospital,Tongji University
Shanghai, Shanghai Municipality, China
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.
Time frame: 3 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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 .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.