Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition

NCT05999370 | Recruiting

• 1 other identifier: 37-2021-6990
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehabilitation; Malnutrition; Physical Functional Performance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adherence to the exercise intervention

  from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps

• Adherence to the nutrition intervention

  from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence

• Adherence to the nutrition intervention

  from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence

Study Arms (2)

Nutrition and exercise

OTHER

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; Behavioral: Exercise

Nutrition only

OTHER

The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.

Behavioral: Nutrition

Interventions

Nutrition BEHAVIORAL

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.

Nutrition and exercise; Nutrition only

Exercise BEHAVIORAL

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.

Nutrition and exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• McGill University: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

MUHC Research Ethics Board

Montreal, Quebec, H4A 3T2, Canada

RECRUITING

Related Publications (5)

• 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.

  PMID: 34587460 BACKGROUND

• 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.

  PMID: 31968063 BACKGROUND

• 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.

  PMID: 29750973 BACKGROUND

• 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.

  PMID: 28385477 BACKGROUND

• 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.

  PMID: 33041092 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Interventions

Nutritional Status; Exercise

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chelsia Gillis, RD PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelsia Gillis, RD PhD

CONTACT

514-398-7905; chelsia.gillis@mcgill.ca

Natalia Tomborelli Bellafronte, RD PhD

CONTACT

natbella@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 21, 2023
• Study Start: January 31, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)