Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition

May 6, 2025 updated by: Chelsia Ann Gillis, McGill University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3T2
        • Recruiting
        • MUHC Research Ethics Board
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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".
Behavioral: Nutrition

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.

Behavioral: Exercise
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.
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.
Behavioral: Nutrition

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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.
from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps
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)
from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence
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)
from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Collaborators

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

Investigators

  • Principal Investigator: Chelsia Gillis, RD PhD, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37-2021-6990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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