Impact of a fasting mimicking diet on recovery in 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

This study is testing if a special diet that mimics fasting can help colorectal cancer patients recover better after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 602 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (Shanghai, Shanghai and 5 other locations)
• Trial ID: NCT05384444 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of a fasting mimicking diet (FMD) on the postoperative recovery and outcomes of patients undergoing radical surgery for colorectal cancer. It aims to determine whether FMD can enhance the vulnerability of cancer cells to treatment while protecting healthy cells, thereby improving recovery. The study focuses on patients aged 18 to 80 who are undergoing their first radical colorectal cancer resection and have specific health criteria. The intervention involves implementing a cyclic FMD regimen during the postoperative period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 undergoing their first radical colorectal cancer surgery with a clinical tumor stage of III.

Not a fit: Patients with distant metastasis, prior chemotherapy, or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve recovery times and outcomes for colorectal cancer patients after surgery.

How similar studies have performed: Previous studies have shown that fasting mimicking diets are safe and feasible for cancer patients undergoing chemotherapy, but this specific application in postoperative colorectal cancer patients is novel.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai and 5 other locations

• Fudan University Huashan Hospital — Shanghai, Shanghai, China (Recruiting)
• Fudan University Shanghai Cancer center — Shanghai, Shanghai, China (Recruiting)
• Fudan University,ZhongShan Hospital — Shanghai, Shanghai, China (Recruiting)
• Shanghai Changhai Hospital, Naval Medical University, — Shanghai, Shanghai, China (Recruiting)
• Shanghai First People's Hospital,Shanghai Jiaotong University — Shanghai, Shanghai, China (Recruiting)
• Shanghai Tongji Hospital,Tongji University — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Miaomiao Guo, Dr — Shanghai Zhongshan Hospital
• Study coordinator: Changhong Miao, PhD

Conditions Fasting Mimicking Diet; Colorectal Cancer