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

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ClinicalTrials.gov Identifier: NCT01727570
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : November 20, 2014
Sponsor:
Collaborator:
Immunotec Inc.
Information provided by (Responsible Party):
Franco Carli, McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: Whey Protein (Immunocal®) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
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
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727570


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Franco Carli, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01727570     History of Changes
Other Study ID Numbers: 11-240-SDR
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

Keywords provided by Franco Carli, 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