Clinical trial · Interventional
Effect of FMD on Colorectal Cancer Patients
Effect of Perioperative Dietary Restriction Strategy on Postoperative Recovery and Outcomes of Patients With Colorectal Cancer : a Multicenter Prospective, Randomized, Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Fasting Mimicking Diet | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fasting mimicking diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fasting mimicking diet
- description
- 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.
- interventionNames
- Other: Fasting mimicking diet
- type
- NO_INTERVENTION
- label
- regular diet
- description
- regular diet
Primary outcomes (1)
- measure
- Disease-free Survival
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGuo M, Sun Z, Zhong Z, Hu H, Qiu Y, Liu S, Yimin N, Tong C, Liang F, Ji C, Xu J, Deng X, Miao C. Effects of a fasting-mimicking diet on long-term prognosis in patients with colorectal cancer undergoing radical resection: protocol for a multicentre, prospective, randomised controlled trial. BMJ Open. 2026 Jul 9;16(7):e121738. doi: 10.1136/bmjopen-2026-121738. PMID 42425570