Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity

Study Overview
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Brief Summary
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To determine the impact of nutritional supplementation with whey protein on postoperative functional capacity in patients undergoing colorectal surgery for cancer.It is hypothesized that, compared with a control group receiving nutrition counselling only, patients receiving nutritional counselling along with preoperative and postoperative nutritional supplements will have a significantly improved change in functional walking capacity from baseline to 8 weeks after surgery.

Detailed Description
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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.

Official Title
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Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: Whey Protein (Immunocal®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: +18 years of age referred electively for resection of malignant, non metastasized, colorectal lesions French or English speaking Exclusion Criteria: ASA class 4-5 co-morbid medical, physical and mental conditions (e.g.dementia, disabling orthopedic and neuromuscular disease, psychosis) cardiac abnormalities severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV), COPD, renal failure (creatinine > 1.5 mg/dl, and hepatic failure ALT and AST >50% over the normal range) sepsis morbid obesity (BMI >40) anemia (hematocrit < 30 %, haemoglobin <10g/dl, albumin < 25mg/dl).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Nutrition Counselling<br>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<br>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®)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Minute Walk Test (6MWT) | 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. | up to 8 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Colon, Rectum, Surgery