Effect of Multimodal Prehabilitation After Colorectal Cancer Surgery

NCT05854394 | Unknown DMC

• 1 other identifier: NCT20211154469
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. This is a prospective randomized controlled trail, designed to explore if the patients who take Colorectal Cancer Surgery will benefit from short-term multimodal prehabilitation strategy. multimodal prehabilitation includes exercise, nutrition supplement and physiology management preoperatively. It starts from the day that patients decide to take the surgery until the day before surgery, lasting 1\~2 week in The First Affiliated Hospital of Xiamen University. And investigators follow-up patients until 4 weeks after surgery to investigate if multimodal prehabilitation strategy can improve the postoperative functional recovery and improve the quality of life #reduce complications and improve prognosis.

Conditions

Colorectal Cancer

Keywords

Prehabilitation; Quality of life; Cancer-related fatigue; Colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 6-minute-walking-distance (6MWD)

  Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.

  [Time Frame: 4 weeks postoperatively]

Secondary Outcomes (2)

• Cancer-related fatigue

  [Time Frame: 4 weeks postoperatively]

• Quality of Life Scale

  [Time Frame: 4 weeks postoperatively]

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

Multimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise and respiratory training ), nutritional suggestion and optimization#whey protein supplement#, and psychological therapy, as well as conventional guidance (including drug treatment recommendations for chronic disease, quit smoking and abstinence).

Behavioral: Multimodal prehabilitation management Multimodal prehabilitation management

Control group

NO INTERVENTION

The patients will receive the conventional clinical guidance according to The First Affiliated Hospital of Xiamen University, including drug treatment recommendations for chronic disease, quit smoking and abstinence.

Interventions

Multimodal prehabilitation management Multimodal prehabilitation management BEHAVIORAL

Multimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise ), nutritional suggestion and optimization（whey protein supplement）, and psychological therapy, as well as conventional guidance (including drug treatment recommendations for chronic disease, quit smoking and abstinence).

Prehabilitation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• From 18 y/o to 75 y/o
• Suspected of colorectal cancer
• Decide to take the colorectal cancer radical surgery in The First Hospital Affiliated to Xiamen University
• Patients with post-operative pathological diagnosis of colorectal cancer

You may not qualify if:

• Refuse or fail to cooperate the study (due to any reason)
• Unable to tolerate prehabilitaion strategy (including exercise guide, whey protein and psycho-relaxation exercise)
• Other severe cardio-pulmonary diseases that would affect the 6MWD

Sponsors & Collaborators

• Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, FuJian Provice, 361000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

JiaJun Zhang, Master of Medicine

CONTACT

+8618298370130; zjiajunmail@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: patients were randomly assigned to the prehabilitation group and control group by online randomization software

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 11, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)