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

Plain Language Summary

Simplified for easier understanding

This study tests whether a structured exercise and nutrition program (called prehabilitation) in the weeks before surgery can improve recovery outcomes for older patients with colorectal cancer who have low physical fitness or malnutrition. **You may be eligible if...** - You are 65 years or older - You have been diagnosed with colorectal cancer and are scheduled for surgery to remove part of the colon or rectum - You have low physical fitness (walking less than 400 meters in a 6-minute walk test) - You have signs of malnutrition (a nutrition assessment score of 9 or higher) - You speak English or French, or have someone with you who can translate **You may NOT be eligible if...** - You have conditions that make exercise unsafe (such as dementia, Parkinson's disease, or previous stroke with weakness) - Your cancer has spread to other organs (metastatic) - You do not speak English or French and cannot bring someone to assist Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.