Colorectal Cancer, Fasting Mimicking Diet
Conditions
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.
Interventions
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.
Sponsors
Fudan University
Shanghai Cancer Hospital, China
Huashan Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Tongji Hospital
Changhai Hospital
Shanghai Zhongshan Hospital
Study design
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
Intervention model description
Concealed allocation: the statisticians formulate the randomization scheme and generates the random number.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 3 years | 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. |
| Weight and BMl | Dietary intervention phase (up to 4 months) and 6 months after surgery | 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. |
| upper arm circumference and waist circumference | Dietary intervention phase (up to 4 months) and 6 months after surgery | 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. |
| plasma albumin | Dietary intervention phase (up to 4 months) and 6 months after surgery | 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. |
| Nutritional status | Dietary intervention phase (up to 4 months) and 6 months after surgery | 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. |
| Quality of life (QOL) | Dietary intervention phase (up to 4 months) and 6 months after surgery | 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. |
| Exercise tolerance | Dietary intervention phase (up to 4 months) and 6 months after surgery | 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. |
| Chemotherapy-related toxicities | within 2 weeks after each chemotherapy cycle | 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). |
| insulin-like growth factor 1 (IGF-1) | 4 months | 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 . |
| Fasting serum glucose (FG) | 4 months | 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. |
| Fasting insulin (FI) | 4 months | 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. |
| C-peptide | 4 months | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMiaomiao Guo, Dr
Shanghai Zhongshan Hospital
PRINCIPAL_INVESTIGATORMeilin Weng, PhD
Shanghai Zhongshan Hospital
Outcome results
None listed