Colorectal Cancer
Conditions
Keywords
Cancer, Colon, Rectum, Surgery
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.
Interventions
DIETARY_SUPPLEMENTWhey 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.
Sponsors
Immunotec Inc.
Franco Carli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed