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OpenTrials
Completed

NCT Number: NCT02502760

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

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Center; Montreal General Hospital, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

physical exercise program

Behavioral

Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.

Whey Protein Isolate Powder

Dietary Supplement

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

Relaxation Techniques

Behavioral

Relaxation techniques consisting of breathing exercises and using a relaxation CD.

Primary outcomes

  1. Post operative complications

    Time frame: 30 days after surgery

    Comprehensive Complication Index (CCI)

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Sir Mortimer B. Davis - Jewish General Hospital

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 20, 2015
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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