Malnutrition Clinical Trial
Official 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
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
Canada | MUHC Research Ethics Board | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University | McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474. Erratum In: JAMA Surg. 2020 Mar 1;155(3):269. — View Citation
Gillis C, Buhler K, Bresee L, Carli F, Gramlich L, Culos-Reed N, Sajobi TT, Fenton TR. Effects of Nutritional Prehabilitation, With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: A Systematic Review and Meta-analysis. Gastroenterology. 2018 Aug;155(2):391-410.e4. doi: 10.1053/j.gastro.2018.05.012. Epub 2018 May 8. — View Citation
Gillis C, Fenton TR, Gramlich L, Keller H, Sajobi TT, Culos-Reed SN, Richer L, Awasthi R, Carli F. Malnutrition modifies the response to multimodal prehabilitation: a pooled analysis of prehabilitation trials. Appl Physiol Nutr Metab. 2022 Feb;47(2):141-150. doi: 10.1139/apnm-2021-0299. Epub 2021 Sep 29. — View Citation
Gillis C, Fenton TR, Gramlich L, Sajobi TT, Culos-Reed SN, Bousquet-Dion G, Elsherbini N, Fiore JF Jr, Minnella EM, Awasthi R, Liberman AS, Boutros M, Carli F. Older frail prehabilitated patients who cannot attain a 400 m 6-min walking distance before colorectal surgery suffer more postoperative complications. Eur J Surg Oncol. 2021 Apr;47(4):874-881. doi: 10.1016/j.ejso.2020.09.041. Epub 2020 Oct 5. — View Citation
Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preoperative six-minute walking distance | 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 | Adherence to the exercise intervention | 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 | |
Secondary | Adherence to the nutrition intervention | 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 | |
Secondary | Adherence to the nutrition intervention | 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 |
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