Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502760
• Other study ID #: 15-131-MUHC
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: June 19, 2019

Study information

• Verified date: August 2019
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Colorectal cancer patient undergoing resection

• Frail or intermediately frail patients (Fried score 2 and above)

Exclusion Criteria:

• Unable to communicate in French or English

• Premorbid conditions contraindicating physical exercise (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Behavioral:
• Physical Exercise Program
Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.

Dietary Supplement:
• Whey Protein Isolate Powder
Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Powder (Immunocal) is provided. Immunocal1.5g/kg PO (by mouth) per day separated in 2 daily doses

Behavioral:
• Relaxation Techniques
Relaxation techniques consisting of breathing exercises and using a relaxation CD.

Locations

Country	Name	City	State
Canada	McGill University Health Center; Montreal General Hospital	Montreal	Quebec
Canada	Sir Mortimer B. Davis - Jewish General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost Effectiveness of treatment	Factoring the cost of the program versus possible savings related to other primary and secondary outcomes	30 days after hospital discharge
Primary	Post operative complications	Comprehensive Complication Index (CCI)	30 days after surgery
Secondary	6 Minutes Walk Test Distance		4 weeks after discharge
Secondary	Hospital Length of Stay		3-6 days
Secondary	Readmission rates		30 days after discharge
Secondary	Anxiety and Depression	Using the Hospital Anxiety Depression Scale (HADS)	30 days after discharge
Secondary	Health Related Quality of Life	Using the Short Form Health Survey (SF-36)	30 days after discharge