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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
MUHC Research Ethics Board
RECRUITING
Montreal
Contact Information
Primary
Chelsia Gillis, RD PhD
chelsia.gillis@mcgill.ca
514-398-7905
Backup
Natalia Tomborelli Bellafronte, RD PhD
natbella@ymail.com
Time Frame
Start Date: 2022-01-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Other: 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.
Other: Nutrition only
The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.
Related Therapeutic Areas
Sponsors
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre
Leads: McGill University

This content was sourced from clinicaltrials.gov