Effects of Fasting Strategies on Postoperative Recovery and Long-term Prognosis in Patients With Colorectal Cancer

NCT04345978 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2020-08-11

No results posted yet for this study

Summary

In 2018, colorectal cancer is the third most common malignant tumor in terms of morbidity and second mortality in the world. Surgical resection is still the main treatment for colorectal cancer.With the introduction of the ERAS, the latest international and domestic guidelines for fasting before surgery all advocate shortening the fasting time. For example, 2 hours before surgery, oral take cleared fluids, including water, sugar water, fruit juice, tea and black coffee (without milk) is allowed.Solid food can be consumed 4 hours before surgery, and oral diet should be resumed as soon as possible after surgery. Changes in diet, nutritional status, and physical activity are closely related to the incidence of colorectal cancer. Therefore, we believe that the intestine may be very sensitive to different fasting times during the perioperative period. Prolonging the fasting time may improve the prognosis by improving postoperative insulin resistance, reducing inflammation and protecting anti-tumor immune function in patients with colorectal cancer.Prolonged fasting time seems to be contrary to the results of some studies, and whether it is applicable to patients with tumor surgery is unclear. Therefore, there is an urgent need to conduct large-scale, prospective, randomized controlled clinical studies to clarify the most suitable perioperative fasting strategy (including composition, interval, and amount) for cancer patients, which can not only reduce surgical stress and speed up postoperative rehabilitation,reduce postoperative metastasis and recurrence and improve mid- and long-term prognosis.

Conditions

Interventions

BEHAVIORAL

Fasting hours

Normal Fasting hours before CRC surgery for 8 hours and feeding 8 hours after surgery; Prolong fasting hours before CRC surgery for 24 hours and feeding 24 hours after surgery.

Sponsors & Collaborators

  • Shanghai Cancer Hospital, China

    collaborator OTHER
  • Huashan Hospital

    collaborator OTHER
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Tongji Hospital

    collaborator OTHER
  • Changhai Hospital

    collaborator OTHER
  • Fudan University

    lead OTHER

Principal Investigators

  • Mengjie Yang, phD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-09-30
Completion
2023-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345978 on ClinicalTrials.gov