NCT05999370 Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition
| NCT ID | NCT05999370 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University |
| Condition | Prehabilitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-01-31 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-01-31 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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;
Contact & Investigator
Chelsia Gillis, RD PhD
PRINCIPAL INVESTIGATOR
McGill University
Frequently Asked Questions
Who can join the NCT05999370 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Prehabilitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05999370 currently recruiting?
Yes, NCT05999370 is actively recruiting participants. Contact the research team at chelsia.gillis@mcgill.ca for enrollment information.
Where is the NCT05999370 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05999370 clinical trial?
NCT05999370 is sponsored by McGill University. The principal investigator is Chelsia Gillis, RD PhD at McGill University. The trial plans to enroll 60 participants.