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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: Whey Protein (Immunocal®)

• Registration Number: NCT01727570
• Lead Sponsor: Franco Carli

Brief Summary

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

The aims of this research project are the following:

1. 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.

2. To understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-16
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition Supplementation	Whey Protein (Immunocal®)	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.

Primary Outcome Measures

Name	Time	Method
Six-Minute Walk Test (6MWT)	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.

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada