Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity
|ClinicalTrials.gov Identifier: NCT01727570|
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : November 20, 2014
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Dietary Supplement: Whey Protein (Immunocal®)|
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|
|Primary Completion Date :||October 2013|
|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.
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 Center|