Status:

RECRUITING

Effect of FMD on Colorectal Cancer Patients

Lead Sponsor:

Fudan University

Collaborating Sponsors:

Shanghai Cancer Hospital, China

Huashan Hospital

Conditions:

Fasting Mimicking Diet

Colorectal Cancer

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief 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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

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

Key Trial Info

Start Date :

June 8 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 30 2025

Estimated Enrollment :

602 Patients enrolled

Trial Details

Trial ID

NCT05384444

Start Date

June 8 2022

End Date

October 30 2025

Last Update

January 5 2024

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Fudan University Huashan Hospital

Shanghai, Shanghai Municipality, China, 200032

2

Fudan University Shanghai Cancer center

Shanghai, Shanghai Municipality, China, 200032

3

Fudan University,ZhongShan Hospital

Shanghai, Shanghai Municipality, China, 200032

4

Shanghai Changhai Hospital, Naval Medical University,

Shanghai, Shanghai Municipality, China, 200032