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

NCT01727570 | Completed DMC

• 1 other identifier: 11-240-SDR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Cancer; Colon; Rectum; Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nutrition Counselling

NO INTERVENTION

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

Nutrition Supplementation

ACTIVE COMPARATOR

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®)

Interventions

Whey Protein (Immunocal®) DIETARY_SUPPLEMENT

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.

Nutrition Supplementation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• +18 years of age
• referred electively for resection of malignant, non metastasized, colorectal lesions
• French or English speaking

You may not qualify if:

• 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).

Sponsors & Collaborators

• Franco Carli: lead
• Immunotec Inc.: collaborator

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3H2R9, Canada

Location

Related Publications (1)

• 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.

  PMID: 25547338 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Franco Carli, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 16, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

CA (1)