History of Changes for Study: NCT05854394

Effect of Multimodal Prehabilitation After Colorectal Cancer Surgery

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Version	A	B	Submitted Date	Changes
1			May 10, 2023	None (earliest Version on record)

Study Identification


Unique Protocol ID:	NCT20211154469
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
Secondary IDs:

Study Status


Record Verification:	May 2023
Overall Status:	Recruiting
Study Start:	April 1, 2023
Primary Completion:	December 1, 2023 [Anticipated]
Study Completion:	December 31, 2023 [Anticipated]

First Submitted:	April 25, 2023
First Submitted that Met QC Criteria:	May 10, 2023
First Posted:	May 11, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	May 10, 2023
Last Update Posted:	May 11, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Xiamen University
Responsible Party:	Principal Investigator Investigator: JiaJun Zhang Official Title: Principal Investigator Affiliation: Xiamen University
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.).

Conditions


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

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
	patients were randomly assigned to the prehabilitation group and control group by online randomization software
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	100 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Prehabilitation group

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

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).

No Intervention: Control group

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.

Outcome Measures


Primary Outcome Measures:
1.	6-minute-walking-distance (6MWD) [ Time Frame: [Time Frame: 4 weeks postoperatively] ] Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.
Secondary Outcome Measures:
1.	Cancer-related fatigue [ Time Frame: [Time Frame: 4 weeks postoperatively] ] 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.
2.	Quality of Life Scale [ Time Frame: [Time Frame: 4 weeks postoperatively] ] 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.

Eligibility


Minimum Age:	18 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	JiaJun Zhang, Master of Medicine Telephone: +8618298370130 Email: zjiajunmail@163.com
Locations:	China, FuJian Provice
	The First Affiliated Hospital of Xiamen University [Recruiting] Xiamen, FuJian Provice, China, 361000 Contact:Contact: JiaJun Zhang, Master of Medicine +8618298370130 zjiajunmail@163.com

IPDSharing


Plan to Share IPD:	Yes
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
	Time Frame:
	Access Criteria:
	URL:

References


Citations:
Links:
Available IPD/Information: