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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02502760
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Sir Mortimer B. Davis - Jewish General Hospital
Information provided by (Responsible Party):
Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Behavioral: Physical Exercise Program Dietary Supplement: Whey Protein Isolate Powder Behavioral: Relaxation Techniques Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Study Start Date : August 2015
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : June 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

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.




Primary Outcome Measures :
  1. Post operative complications [ Time Frame: 30 days after surgery ]
    Comprehensive Complication Index (CCI)


Secondary Outcome Measures :
  1. 6 Minutes Walk Test Distance [ Time Frame: 4 weeks after discharge ]
  2. Hospital Length of Stay [ Time Frame: 3-6 days ]
  3. Readmission rates [ Time Frame: 30 days after discharge ]
  4. Anxiety and Depression [ Time Frame: 30 days after discharge ]
    Using the Hospital Anxiety Depression Scale (HADS)

  5. Health Related Quality of Life [ Time Frame: 30 days after discharge ]
    Using the Short Form Health Survey (SF-36)


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502760


Locations
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Canada, Quebec
McGill University Health Center; Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
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Principal Investigator: Franco Carli, MD, MPhil Professor, Department of Anesthesia

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Responsible Party: Franco Carli, Professor, Montreal General Hospital Department of Anesthesia, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02502760    
Other Study ID Numbers: 15-131-MUHC
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Postoperative Complications
Perioperative Care
Colorectal Surgery
Frail Elderly
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases