Improving health before colorectal cancer surgery for older patients with 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
This study is testing whether older patients with colorectal cancer who are malnourished can do better before surgery by focusing on nutrition alone or nutrition plus exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | McGill University Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05999370 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of nutrition prehabilitation alone versus nutrition combined with supportive exercise for older colorectal cancer patients who are malnourished and have low physical function. The study focuses on patients aged 65 and older who are scheduled for primary colorectal surgery and have a six-minute walking distance (6MWD) of less than 400 meters. By addressing malnutrition, the researchers aim to improve patients' physical performance before surgery, potentially enhancing surgical outcomes. The trial will measure adherence to interventions and the impact on achieving a clinically significant improvement in walking distance.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 and older with colorectal cancer scheduled for surgery, who have a 6MWD of less than 400 meters and a malnutrition assessment score of 9 or higher.
Not a fit: Patients with metastatic cancer or those with conditions that contraindicate exercise, such as dementia or Parkinson's disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve preoperative physical function and overall outcomes for malnourished colorectal cancer patients.
How similar studies have performed: While the approach of combining nutrition and exercise is established, this specific focus on malnourished older patients with colorectal cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Montreal, Quebec
- MUHC Research Ethics Board — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Chelsia Gillis, RD PhD — McGill University
- Study coordinator: Chelsia Gillis, RD PhD
- Email: chelsia.gillis@mcgill.ca
- Phone: 514-398-7905
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.