Effect of Multimodal Prehabilitation After Colorectal Cancer Surgery

Trial Title: Effect of Multimodal Prehabilitation After Colorectal Cancer Surgery

NCT ID: NCT05854394

Condition: Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
Prehabilitation
Quality of life
Cancer-related fatigue
Colorectal cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: patients were randomly assigned to the prehabilitation group and control group by online randomization software

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Multimodal prehabilitation management Multimodal prehabilitation management
Description: 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).
Arm group label: Prehabilitation group

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.

Detailed description: 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. It has been confirm that trimodal prehabilitation strategy including exercise, diet and psychology guidance could improve postoperative functional recovery after surgery for patients undergoing colorectal resection. Although many clinical studies have confirmed that preoperative exercise for patients undergoing colorectal cancer surgery is safe and useful, but the prehabilitation strategy in previous studies usually takes 4~8 weeks. However, patient suspected of malignant tumor often wouldn't wait for such a long period. Investigators therefore designed this study to investigate if a 1~2 week multimodal prehabilitation strategy benefits the patients undergoing laparoscopic colorectal cancer resection. There will be 100 patients awaiting operation for primary colorectal cancer recruited in this research at The First Affiliated Hospital of Xiamen University. After informed consent was obtained, the patients will be divided into two groups randomly, the prehibilitation group and control group. The prehabilitation group will receive an individual trimodal prehabilitation strategy after a complete assessment, including physical exercise, nutritional optimization, and psychological therapy, as well as conventional guidance. The length of prehabilitation was determined by the waiting time till surgery alone. The control group will receive the conventional guidance, including drug treatment recommendations for chronic disease, quit smoking and abstinence. Both of the groups are also provided some useful information about surgery process. The functional capability will be examined for both groups at several time points (baseline, the day before surgery,4 weeks postoperatively) The primary end point is functional walking capacity as measured by the 6 minutes walking distance (6MWD) 4 weeks postoperatively, health-related quality of life scales and cancer-related fatigue. The secondary end points include self-reported physical activity, and prognosis information (postoperative complications, length of hospital stay, ICU stay time, hospitalization expenses, etc.).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Exclusion Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Affiliated Hospital of Xiamen University

Address:
City: Xiamen
Zip: 361000
Country: China

Status: Recruiting

Contact:
Last name: JiaJun Zhang, Master of Medicine

Phone: +8618298370130
Email: zjiajunmail@163.com

Start date: April 1, 2023

Completion date: December 31, 2023

Lead sponsor:
Agency: Xiamen University
Agency class: Other

Source: Xiamen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05854394