Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity
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|ClinicalTrials.gov Identifier: NCT01727570|
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : November 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Dietary Supplement: Whey Protein (Immunocal®)||Not Applicable|
The aims of this research project are the following:
- Determine to what extent a nutritional prehabilitation regimen, which includes whey protein, initiated before surgery and continued after surgery, optimizes the recovery of functional walking capacity following colorectal resection for cancer.
- To understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
No Intervention: Nutrition Counselling
Patients will be asked to fill out a three day record of all food and drink consumed. Patients will be given an appointment with the nutritionist approximately 4 weeks before surgery to go over their regular diet and advice will be given on how to improve the nutritional quality of their diet
Active Comparator: Nutrition Supplementation
Patients will be asked to fill out a three day record of all food and drink consumed. An appointment with the nutritionist will be given approximately 4 weeks before surgery to go over their regular diet and advice will be given on how to improve the nutritional quality of the diet. Patients will also be given a supply of nutritional supplements to take orally (by mouth) every day. These supplements include a whey protein isolate (Immunocal®, Immunotec Inc), omega-3 fatty acids from fish oil, and vitamins/minerals.
Dietary Supplement: Whey Protein (Immunocal®)
The amount of Immunocal® whey protein the patient is required to take daily will be determined on an individual basis by the nutritionist according to the assessed protein deficit in the patient's diet.
- Six-Minute Walk Test (6MWT) [ Time Frame: up to 8 weeks after surgery ]Change in functional walking capacity will be assessed throughout the study according to the 6-Minute Walk Test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.
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): NCT01727570
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3H2R9|
|Principal Investigator:||Franco Carli, MD||McGill University Health Centre/Research Institute of the McGill University Health Centre|