Back to resultsPrehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Whey Protein (Immunocal®)
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring Cancer, Colon, Rectum, Surgery
Eligibility Criteria
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).
Sites / Locations
- Montreal General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Nutrition Counselling
Nutrition Supplementation
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01727570
First Posted
October 31, 2012
Last Updated
November 18, 2014
Sponsor
Franco Carli
Collaborators
Immunotec Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01727570
Brief Title
Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity
Official Title
Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Franco Carli
Collaborators
Immunotec Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Cancer, Colon, Rectum, Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition Counselling
Arm Type
No Intervention
Arm Description
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
Arm Title
Nutrition Supplementation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein (Immunocal®)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six-Minute Walk Test (6MWT)
Description
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.
Time Frame
up to 8 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Carli, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H2R9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25547338
Citation
Gillis C, Nguyen TH, Liberman AS, Carli F. Nutrition adequacy in enhanced recovery after surgery: a single academic center experience. Nutr Clin Pract. 2015 Jun;30(3):414-9. doi: 10.1177/0884533614562840. Epub 2014 Dec 29.
Results Reference
derived
Learn more about this trial
Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity
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