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| Name | Class |
|---|---|
| Shanghai Cancer Hospital, China | OTHER |
| Huashan Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting mimicking diet | Experimental | 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. |
|
| regular diet | No Intervention | regular diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting mimicking diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Weight and BMl |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome | Safety will be assessed in participants following at least one administration of the FMD regimen. Adverse events occurring during the intervention period will be recorded at each follow-up contact and graded according to CTCAE v5.0. The investigators will assess the severity of each event and its potential relationship with FMD intervention. Safety outcomes will include the frequency and severity of FMD-related adverse events. Predefined FMD-related adverse events include headache, weakness, fatigue, hunger, gastrointestinal symptoms, hypoglycemia, electrolyte abnormalities, and clinically significant weight loss. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miaomiao Guo, Dr | Shanghai Zhongshan Hospital | Principal Investigator |
| Meilin Weng, PhD | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Huashan Hospital | Shanghai | Shanghai Municipality | 200032 | China | ||
| Fudan University Shanghai Cancer center |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Tongji Hospital |
| OTHER |
| Changhai Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
Concealed allocation: the statisticians formulate the randomization scheme and generates the random number.
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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
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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.
| 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. | 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. | 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. | 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. | 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. | 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). | 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 . | 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. | 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. | 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. | 4 months |
| Dietary intervention phase (up to 4 months) |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| Fudan University,ZhongShan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai Changhai Hospital, Naval Medical University, | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai First People's Hospital,Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai Tongji Hospital,Tongji University | Shanghai | Shanghai Municipality | 200032 | China |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |