Effect of FMD on Colorectal Cancer Patients

Last updated: January 4, 2024
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Cancer

Treatment

Fasting mimicking diet

Clinical Study ID

NCT05384444
B2020-063(2)
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 autoimmunesystem or long-term using of glucocorticoids or immunosuppressant
  6. History of opioid abuse, mental illness or cognitive impairment

Study Design

Total Participants: 602
Treatment Group(s): 1
Primary Treatment: Fasting mimicking diet
Phase:
Study Start date:
June 08, 2022
Estimated Completion Date:
October 30, 2025

Connect with a study center

  • Fudan University Huashan Hospital

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer center

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Fudan University,ZhongShan Hospital

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanghai Changhai Hospital, Naval Medical University,

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanghai First People's Hospital,Shanghai Jiaotong University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Shanghai Tongji Hospital,Tongji University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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