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Behavioral Intervention

Prehabilitation for Colorectal Cancer

N/A
Recruiting
Led By Chelsia Gillis, RD PhD
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps
Awards & highlights

Study Summary

This trial found that 60% of older colorectal cancer patients w/ poor physical function couldn't reach pre-op walking goal. Malnutrition was linked to worse functioning & more than twice as many <400m patients were malnourished. Nutritional deficiency may prevent reaching walking goal & improve outcomes.

Who is the study for?
This trial is for older adults (65+) with colorectal cancer who are malnourished and have a low walking distance (less than 400m in six minutes). They must be scheduled for surgery but not have metastatic cancer or conditions like dementia, Parkinson's, or stroke that would make exercise unsafe.Check my eligibility
What is being tested?
The study tests if improving nutrition alone can help patients walk farther before surgery. It focuses on those unable to meet the pre-surgery walking goal despite usual prehabilitation, which includes nutrition, exercise, and mental support.See study design
What are the potential side effects?
Since this trial involves nutritional interventions and exercise programs rather than medications, side effects may include muscle soreness from physical activity and potential gastrointestinal changes due to diet adjustments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Preoperative six-minute walking distance
Secondary outcome measures
Adherence to the exercise intervention
Adherence to the nutrition intervention

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nutrition onlyExperimental Treatment1 Intervention
The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.
Group II: Nutrition and exerciseExperimental Treatment2 Interventions
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".
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutrition
2011
Completed Phase 3
~58070
Exercise
2016
Completed Phase 1
~760

Find a Location

Who is running the clinical trial?

McGill UniversityLead Sponsor
399 Previous Clinical Trials
1,000,228 Total Patients Enrolled
6 Trials studying Malnutrition
19,961 Patients Enrolled for Malnutrition
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
450 Previous Clinical Trials
159,786 Total Patients Enrolled
1 Trials studying Malnutrition
1,760 Patients Enrolled for Malnutrition
Chelsia Gillis, RD PhDPrincipal InvestigatorMcGill University

Media Library

Prehabilitation (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05999370 — N/A
Malnutrition Research Study Groups: Nutrition and exercise, Nutrition only
Malnutrition Clinical Trial 2023: Prehabilitation Highlights & Side Effects. Trial Name: NCT05999370 — N/A
Prehabilitation (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05999370 — N/A
~22 spots leftby Dec 2025
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