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NCT05384444Active, not recruiting

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 · Last updated 12 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
602 (estimated)
First submitted
13 Apr 2022
Start date
8 Jun 2022
Primary completion date
30 Oct 2027
Lead sponsor
Fudan University
NCT number
NCT05384444

What you commit to

  • Study type: Interventional
  • Planned participants: 602
  • From 8 Jun 2022 to the primary completion date, 30 Oct 2027
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Evidence of distant metastasis before surgery
  • Before surgery, have received treatment of neoadjuvant chemotherapy

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Huashan Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Shanghai Tongji Hospital,Tongji University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Shanghai First People's Hospital,Shanghai Jiaotong University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Fudan University Zhongshan Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Shanghai Changhai Hospital, Naval Medical University,
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.