NCT04345978|UnknownDMC

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

Effects of Different Fasting Strategies in Perioperative Period on Postoperative Recovery, Immune Function, and Long-term Prognosis in Patients With Radical Resection of Colorectal Cancer

Fudan University ClinicalTrials.gov

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1 other identifier

B2020-063

Study Type

interventional

Target

2,400

Locations

1 country

Sites

Timeline

RegisteredApr 2020

StartedJan 2020

CompletionSep 2023

Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

2,400

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach

1 country

7 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

Study Start

First participant enrolled

January 1, 2020

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed

Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

2.7 years

First QC Date

April 8, 2020

Last Update Submit

August 9, 2020

Conditions

Fasting Immune Suppression Complication of Surgical Procedure Colorectal Cancer

Keywords

FastingImmune SuppressionSurvivalImmune metabolism

Outcome Measures

Primary Outcomes (1)

Disease-free Survival
Defined and calculated as the time from the date of surgery to the first time of colon cancer recurrence or metastasis or cancer-related death
During 2 years after surgery

Secondary Outcomes (11)

Overall Survival
During 2 years after surgery
Postoperative pain score and side effects of patient-controlled analgesia
During the first 48 hours after surgery
Incidence of delirium
During the first 1 week after surgery
Length of stay in hospital after surgery and total costs after surgery
During the first 30 days after surgery
Return of bowel function
During the first 30 days after surgery
+6 more secondary outcomes

Study Arms (2)

Normal Fasting

PLACEBO COMPARATOR

The patient starts fasting 8 hours before the operation,and does not take any solid or liquid foods and nutrients during the fasting process.The fasting period does not strictly limit the consumption of pure water,After surgery 8 hours,the patients was allowed to feeding.

Behavioral: Fasting hours

Prolong Fasting

EXPERIMENTAL

The patient starts fasting 24 hours before the operation, and does not take any solid or liquid foods and nutrients during the fasting process. The fasting period does not strictly limit the consumption of pure water.After surgery 24 hours,the patients was allowed to feeding.

Behavioral: Fasting hours

Interventions

Fasting hoursBEHAVIORAL

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.

Normal FastingProlong Fasting

Eligibility Criteria

Age20 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 20 \~ 70 years old
With BMI 20.5-25.0 kg/m2
Without any Endocrine and metabolic diseases
A stable body weight (±3 kg) for at least 6 months
Those diagnosed with colorectal cancer by preoperative pathology or enteroscopy
Patients undergoing laparoscopic radical colorectal cancer resection
ASA grade I-III grade
Initial patients have not received any treatment for bowel cancer except neoadjuvant chemotherapy
Patients with confirmed and feasible radical resection of colorectal cancer
No evidence of distant metastasis before surgery
Willing to participate in the research of the subject and agree to follow up regularly

You may not qualify if:

Patients with relapsed colorectal cancer who are going to undergo surgery and re-excision
accompanied by other malignant tumors
Severe malnourished patients
History of systemic metabolism such as diabetes
Before surgery, have received other treatments for colorectal cancer (such as local excision, etc.) in addition to neoadjuvant chemotherapy
Have a history of immunotherapy before surgery
Combined with basic diseases of serious heart, lung, brain, kidney and other important organs
Combined with severe primary diseases such as severe immune system or hematopoietic system
The tumor burden cannot be cured, and there is distant metastasis. Those who intend to undergo palliative surgery
People with gastroesophageal reflux disease, difficulty swallowing, intestinal obstruction, or difficulty in airway management
People who refuse to participate in the study or cannot receive long-term follow-up

Contact the study team to confirm eligibility.