RecruitingNot ApplicableNCT05999370

Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition

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

Sponsor

McGill University

Enrollment

60 participants

Start Date

Jan 31, 2022

Study Type

INTERVENTIONAL

Conditions

Prehabilitation Malnutrition Physical Functional Performance

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

Min Age: 65 Years

Inclusion Criteria4

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 Criteria3

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;

Interventions

BEHAVIORALNutrition

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.

BEHAVIORALExercise

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.