Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prehabilitation, Malnutrition, Physical Functional Performance

Intervention / Treatment
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* Behavioral: Nutrition
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nutrition and exercise<br>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<br>* 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.<br>Behavioral: Exercise<br>* 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.<br>|
| Other: Nutrition only<br>The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets. | Behavioral: Nutrition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative six-minute walking distance | 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). | from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in meters | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the exercise intervention | Adherence will be monitored by use of logbooks and a smart watch (FitBit), which records daily steps. | from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps | 
| Adherence to the nutrition intervention | 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) | from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence | 
| Adherence to the nutrition intervention | 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) | from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence |