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Trial Title:
Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition
NCT ID:
NCT05999370
Condition:
Prehabilitation
Malnutrition
Physical Functional Performance
Conditions: Official terms:
Malnutrition
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Nutrition
Description:
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.
Arm group label:
Nutrition and exercise
Arm group label:
Nutrition only
Intervention type:
Behavioral
Intervention name:
Exercise
Description:
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.
Arm group label:
Nutrition and exercise
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.
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.
Criteria for eligibility:
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;
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MUHC Research Ethics Board
Address:
City:
Montréal
Zip:
H4A 3T2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Elizabeth Craven, PhD
Phone:
514 934-1934
Phone ext:
22319
Email:
reb.ct1@muhc.mcgill.ca
Start date:
January 31, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
McGill University
Agency class:
Other
Collaborator:
Agency:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Agency class:
Other
Source:
McGill University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05999370
