search
Back to results

Effect of Multimodal Prehabilitation After Colorectal Cancer Surgery

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multimodal prehabilitation management Multimodal prehabilitation management
Sponsored by
Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Prehabilitation, Quality of life, Cancer-related fatigue, Colorectal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Xiamen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prehabilitation group

Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cancer-related fatigue
Use the Cancer Fatigue Scale to measure the fatigue of cancer patients in the last few weeks,The scale has 3 dimensions, include somatic fatigue, emotional fatigue and cognitive fatigue, with 15 entries. The scale is scored on a 5-point scale. Entries 1, 2, 3, 6, 9, 12, and 15 are used to assess somatic fatigue, 5, 8, 11, and 14 are used to assess emotional fatigue, and 4, 7, 10, and 13 are used to assess cognitive fatigue. The scale has a total score of 0-60, with somatic fatigue scoring in the range of 0-28, emotional fatigue and cognitive fatigue both scoring in the range of 0-16, and the higher the score, the more severe the fatigue.
Quality of Life Scale
Use the SF-36 to evaluate the intermediate phase of recovery.The full scale consists of 25 items, including four dimensions and eight individual items, which are disease information (4 items), medical examination information (3 items), treatment information (6 items), and other service information (6 items). The scale was based on the Likert 4 scale, with answers of "not at all", "somewhat", "quite", and "very "The scores of each dimension/item were linearly converted to a scale of 0-100 according to the EORTC manual, and then the mean value was taken to obtain the total scale score.

Full Information

First Posted
April 25, 2023
Last Updated
May 10, 2023
Sponsor
Xiamen University
search

1. Study Identification

Unique Protocol Identification Number
NCT05854394
Brief Title
Effect of Multimodal Prehabilitation After Colorectal Cancer Surgery
Official Title
Effect of Multimodal Prehabilitation on Functional Recovery and Quality of Life After Colorectal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Prehabilitation, Quality of life, Cancer-related fatigue, Colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients were randomly assigned to the prehabilitation group and control group by online randomization software
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multimodal prehabilitation management Multimodal prehabilitation management
Intervention 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).
Primary Outcome Measure Information:
Title
6-minute-walking-distance (6MWD)
Description
Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.
Time Frame
[Time Frame: 4 weeks postoperatively]
Secondary Outcome Measure Information:
Title
Cancer-related fatigue
Description
Use the Cancer Fatigue Scale to measure the fatigue of cancer patients in the last few weeks,The scale has 3 dimensions, include somatic fatigue, emotional fatigue and cognitive fatigue, with 15 entries. The scale is scored on a 5-point scale. Entries 1, 2, 3, 6, 9, 12, and 15 are used to assess somatic fatigue, 5, 8, 11, and 14 are used to assess emotional fatigue, and 4, 7, 10, and 13 are used to assess cognitive fatigue. The scale has a total score of 0-60, with somatic fatigue scoring in the range of 0-28, emotional fatigue and cognitive fatigue both scoring in the range of 0-16, and the higher the score, the more severe the fatigue.
Time Frame
[Time Frame: 4 weeks postoperatively]
Title
Quality of Life Scale
Description
Use the SF-36 to evaluate the intermediate phase of recovery.The full scale consists of 25 items, including four dimensions and eight individual items, which are disease information (4 items), medical examination information (3 items), treatment information (6 items), and other service information (6 items). The scale was based on the Likert 4 scale, with answers of "not at all", "somewhat", "quite", and "very "The scores of each dimension/item were linearly converted to a scale of 0-100 according to the EORTC manual, and then the mean value was taken to obtain the total scale score.
Time Frame
[Time Frame: 4 weeks postoperatively]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JiaJun Zhang, Master of Medicine
Phone
+8618298370130
Email
zjiajunmail@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
FuJian Provice
ZIP/Postal Code
361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JiaJun Zhang, Master of Medicine
Phone
+8618298370130
Email
zjiajunmail@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effect of Multimodal Prehabilitation After Colorectal Cancer Surgery

We'll reach out to this number within 24 hrs