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NCT Number: NCT05999370

Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition

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.

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Key information

Conditions

Prehabilitation Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Physical Functional Performance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUHC Research Ethics Board

Montreal, Quebec, H4A 3T2, Canada

Location status: Recruiting

Location contact

Elizabeth Craven, PhD

CONTACT

[email protected]

514 934-1934 ext. 22319

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Nutrition

Behavioral

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.

Exercise

Behavioral

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.

Primary outcomes

  1. Preoperative six-minute walking distance

    Time frame: from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in meters

    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).

Secondary outcomes

  1. Adherence to the exercise intervention

    Time frame: from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps

    Adherence will be monitored by use of logbooks and a smart watch (FitBit), which records daily steps.

  2. Adherence to the nutrition intervention

    Time frame: from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence

    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)

  3. Adherence to the nutrition intervention

    Time frame: from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsia Gillis, RD PhD

CONTACT

[email protected]

514-398-7905

Natalia Tomborelli Bellafronte, RD PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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