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Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition

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ClinicalTrials.gov Identifier: NCT05999370
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
Sponsor:
Collaborator:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Information provided by (Responsible Party):
Chelsia Ann Gillis, McGill University

Study Description
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Brief Summary:
Despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions), 60% of older elective colorectal cancer surgery patients with poor physical function were unable to reach a minimum preoperative 400m six-minute walking distance (6MWD), a prognostic cut-point. Compared to the patients that attained >400m 6MWD preoperatively, twice as many of <400m patients were malnourished. Malnutrition has long been associated with worse functioning (e.g., physical, immune). The investigators hypothesize that for nutritionally deficient patients, the etiology for their poor physical function is malnutrition. Correction of malnutrition alone might thus be sufficient to achieve a 400m 6MWD before surgery and improve patient outcomes.

Condition or disease Intervention/treatment Phase
Prehabilitation Malnutrition Physical Functional Performance Behavioral: Nutrition Behavioral: Exercise Not Applicable

Detailed Description:
The investigators propose a randomized controlled trial of nutrition prehabilitation alone vs nutrition prehabilitation with supportive exercise in patients with malnutrition and 6MWD <400m before elective colorectal surgery. The primary objective, and therapeutic target, will be achievement of minimal clinical important difference for the 6MWD (14m for within group comparisons and 19m between groups). Ability to adhere to the interventions will be monitored. The findings of this study will guide optimal treatment for this vulnerable population by exploring the role of nutrition alone vs. nutrition with exercise to optimize surgical outcomes.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Correction of Malnutrition Sufficient to Improve Low Physical Function Before Elective Colorectal Cancer Surgery? A Randomized Controlled Trial of Nutrition vs Nutrition and Exercise Prehabilitation
Actual Study Start Date : January 31, 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Nutrition and exercise

The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.

The exercise intervention will be personalized based on a comprehensive assessment to include both a resistance and an aerobic component in the form of a "snack".

 Behavioral: Nutrition

The nutrition intervention will be based on needs assessed by indirect calorimetry, patient-generated subjective global assessment, and 24hr recall conducted at baseline, enabling individualized caloric and protein targets.

Deficits in nutrient intake will be addressed with one-on-one dietary counselling and supplementation at baseline in a quantity that matches the estimated deficit in intake. Adherence will be monitored using 24-hr recalls and weight status by the dietitian weekly.


Behavioral: Exercise
The exercise intervention will include both a resistance and an aerobic component to be performed a total of 5 times a day, 5 times per week, 5 minutes each session, totaling 125 minutes per week. The ability to perform exercises as prescribed will be monitored with a weekly in-person or virtual supervised session.
Nutrition only
The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.
 Behavioral: Nutrition

The nutrition intervention will be based on needs assessed by indirect calorimetry, patient-generated subjective global assessment, and 24hr recall conducted at baseline, enabling individualized caloric and protein targets.

Deficits in nutrient intake will be addressed with one-on-one dietary counselling and supplementation at baseline in a quantity that matches the estimated deficit in intake. Adherence will be monitored using 24-hr recalls and weight status by the dietitian weekly.


Outcome Measures
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Primary Outcome Measures :
  1. Preoperative six-minute walking distance [ Time Frame: from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in meters ]
    Physical function will be measured with the six-minute walking test (6MWT). Patients will be instructed to walk back and forth along a 20m hallway, and the distance covered in 6 minutes (6MWD) will be recorded (meters).


Secondary Outcome Measures :
  1. Adherence to the exercise intervention [ Time Frame: from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps ]
    Adherence will be monitored by use of logbooks and a smart watch (FitBit), which records daily steps.

  2. Adherence to the nutrition intervention [ Time Frame: from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence ]
    Adherence to dietary targets (energy intake) will be carefully monitored by weekly in-person or virtual visit using 24hr recalls and supplement counts (energy consumption as compared to prescribed energy targets)

  3. Adherence to the nutrition intervention [ Time Frame: from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence ]
    Adherence to dietary targets (protein intake) will be carefully monitored by weekly in-person or virtual visit using 24hr recalls and supplement counts (protein consumption as compared to prescribed protein targets)


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 65 years and older;
  • Patients with cancer scheduled for primary colorectal resection;
  • Patients with 6MWD at baseline less than 400 m;
  • Patients with Patient-Generated Subjective-Global Assessment (malnutrition assessment) score equal or greater than 9.

Exclusion Criteria:

  • Patients with history of premorbid conditions that contraindicate exercise including dementia, -Parkinson's disease or previous stroke with paresis;
  • Metastatic cancer;
  • Patients who do not speak English or French and cannot be accompanied by someone who speaks English or French;
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): NCT05999370


Contacts
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Contact: Chelsia Gillis, RD PhD 514-398-7905 chelsia.gillis@mcgill.ca
Contact: Natalia Tomborelli Bellafronte, RD PhD natbella@ymail.com

Locations
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Canada, Quebec
MUHC Research Ethics Board Recruiting
Montréal, Quebec, Canada, H4A 3T2
Contact: Elizabeth Craven, PhD    514 934-1934 ext 22319    reb.ct1@muhc.mcgill.ca   
Sponsors and Collaborators
McGill University
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Chelsia Gillis, RD PhD McGill University
More Information
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Publications:

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Responsible Party: Chelsia Ann Gillis, Assistant Professor, McGill University
ClinicalTrials.gov Identifier: NCT05999370    
Other Study ID Numbers: 37-2021-6990
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders