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

August 14, 2019 updated by: Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Center; Montreal General Hospital
      • Montreal, Quebec, Canada, H3T1E2
        • Sir Mortimer B. Davis - Jewish General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation

Immediately after randomization and until surgery, patients in this arm will:

  1. - Receive a personalized physical exercise program
  2. - Receive nutritional counselling with Whey protein isolate powder
  3. - Receive relaxation techniques
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.
Active Comparator: Rehabilitation
Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patients in the other arm but to be started after surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative complications
Time Frame: 30 days after surgery
Comprehensive Complication Index (CCI)
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minutes Walk Test Distance
Time Frame: 4 weeks after discharge
4 weeks after discharge
Hospital Length of Stay
Time Frame: 3-6 days
3-6 days
Readmission rates
Time Frame: 30 days after discharge
30 days after discharge
Anxiety and Depression
Time Frame: 30 days after discharge
Using the Hospital Anxiety Depression Scale (HADS)
30 days after discharge
Health Related Quality of Life
Time Frame: 30 days after discharge
Using the Short Form Health Survey (SF-36)
30 days after discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost Effectiveness of treatment
Time Frame: 30 days after hospital discharge
Factoring the cost of the program versus possible savings related to other primary and secondary outcomes
30 days after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Sir Mortimer B. Davis - Jewish General Hospital

Investigators

  • Principal Investigator: Franco Carli, MD, MPhil, Professor, Department of Anesthesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

June 19, 2019

Study Completion (Actual)

June 19, 2019

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-131-MUHC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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