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Effect of Multimodal Prehabilitation After Colorectal Cancer Surgery

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ClinicalTrials.gov Identifier: NCT05854394
Recruitment Status : Recruiting
First Posted : May 11, 2023
Last Update Posted : May 11, 2023
Sponsor:
Information provided by (Responsible Party):
JiaJun Zhang, Xiamen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Multimodal prehabilitation management Multimodal prehabilitation management Not Applicable

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.).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients were randomly assigned to the prehabilitation group and control group by online randomization software
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Multimodal Prehabilitation on Functional Recovery and Quality of Life After Colorectal Cancer Surgery
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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Arm Intervention/treatment
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
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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 Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05854394


Contacts
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Contact: JiaJun Zhang, Master of Medicine +8618298370130 zjiajunmail@163.com

Locations
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China, FuJian Provice
The First Affiliated Hospital of Xiamen University Recruiting
Xiamen, FuJian Provice, China, 361000
Contact: JiaJun Zhang, Master of Medicine    +8618298370130    zjiajunmail@163.com   
Sponsors and Collaborators
Xiamen University
More Information
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Responsible Party: JiaJun Zhang, Principal Investigator, Xiamen University
ClinicalTrials.gov Identifier: NCT05854394    
Other Study ID Numbers: NCT20211154469
First Posted: May 11, 2023    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JiaJun Zhang, Xiamen University:
Prehabilitation
Quality of life
Cancer-related fatigue
Colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases