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

This study is currently recruiting participants.
Verified April 2013 by McGill University Health Center
Sponsor:
Collaborator:
Immunotec Inc.
Information provided by (Responsible Party):
Franco Carli, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01727570
First received: October 31, 2012
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Cancer
 Dietary Supplement: Whey Protein (Immunocal®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Six-Minute Walk Test (6MWT) [ Time Frame: up to 8 weeks after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727570

Contacts
Contact: Franco Carli, MD 514-934-1934 ext 43274 franco.carli@mcgill.ca

Locations
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3H2R9
Principal Investigator: Franco Carli, MD            
Sponsors and Collaborators
Franco Carli
Immunotec Inc.
Investigators
Principal Investigator: Franco Carli, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: Franco Carli, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01727570     History of Changes
Other Study ID Numbers: 11-240-SDR
Study First Received: October 31, 2012
Last Updated: April 8, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Cancer
Colon
Rectum
Surgery

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013