Effect of EPA Nutritional Supplementation on Markers of Aerobic Performance, Lean Muscle Mass and Quality of Life on Patients Undergoing Curative Resection of Colorectal Cancer
18 Years
85 Years
Both
Colorectal Cancer
Trial Information
Effect of EPA Nutritional Supplementation on Markers of Aerobic Performance, Lean Muscle Mass and Quality of Life on Patients Undergoing Curative Resection of Colorectal Cancer
Cancer is well documented to cause weight loss and cachexia (1). An inflammatory process
driven by the presence of a tumour, can result in reduced food intake (2), increased
metabolic output (3) and loss of skeletal muscle (1). They have reduced fitness and feeling
of lethargy that affects activities of daily living and quality of life. The process
explaining this is not well understood but thought to be due to diminished skeletal muscle
mass and performance. When cancer patients undergo surgery, the trauma of surgery, entails
an inflammatory process that furthermore leads to more of the above (4). Reducing this
inflammatory insult would positively impact fitness, ability to respond to infections,
affect length of stay in hospital, recovery from surgery and quality of life following
surgery.
Eicosapentaenoic acid (EPA) is an omega-3-fatty acid, derived from fish oil and a commonly
available nutritional supplement. It is believed to reduce the inflammatory effect of cancer
and the trauma of surgery, in turn dampening the catabolic effect causing skeletal muscle
loss. Studies on oesophageal cancer patients have previously suggested that EPA can preserve
lean muscle mass (5). The investigators expect EPA to cause less lean muscle loss and
improved aerobic performance. High dietary intake is not thought to have health risks (6)
and EPA has recently been trialed in infant milk formulas with no adverse effects (7).
The investigators plan to recruit patients from colorectal clinic, who are due to have
surgery for colorectal cancer, and give them EPA or placebo, from 5 days prior to surgery to
up to 21 days following surgery. The investigators would like to measure markers of muscle
function and inflammation, muscle mass, exercise performance on by cardiopulmonary exercise
testing, muscle biopsy and muscle grip strength on a dynamometer.
Inclusion Criteria:
- Colorectal cancer patients listed for open curative tumour resection by means of:
Right Hemi Colectomy, Left Hemi-colectomy or Anterior Resection, not having
neo-adjuvant chemotherapy.
- Aged 18 - 85 years old.
Exclusion Criteria:
- Strenuous exercise 48 hours before the preoperative assessment.
- Intramuscular injections within 48 hours of any study day.
- Known peripheral neuropathy or myopathy.
- Patients with mobility problems, wheelchair bound or have suffered a previous
cerebro-vascular accident with residual impairment of mobility.
- Patients with major/ minor trauma (Motor vehicle accidents or ground falls, firearm
injury, drowning, struck by and against injuries).
- Pregnant women. Pregnancy test will be done at the beginning of the study day.
- Patients without mental capacity to give signed consent.
- Patients already taking fish-oil derived nutritional supplement.
- Patients with impaired oral intake.
- Patients known to have metastatic disease.
- Patients having neoadjuvant chemotherapy prior to resection, which may confound
results.
- Patients having laparoscopic procedures.
- Patients identified having cardiorespiratory comorbidity considered unsuitable for
surgery: unstable angina, myocardial infarction within last 3 months, severe aortic
stenosis, pulmonary hypertension, HOCM, acute myopericarditis, chronic heart failure
New York Heart Association class 3 and above and impaired left ventricular ejection
fraction (less than 43%). Respiratory contraindications include severe COPD,
emphysema, fibrosing alveolitis, Interstitial lung disease and FEV1 less than 1.5.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Nutritional supplementation with 960mg EPA three times a day positively affects muscle function and mass
Outcome Description:
Muscle function and mass will be assessed by muscle biopsies, assays of cellular aerobic function and DEXA scan and inflammation (measuring cellular markers of inflammation).
Outcome Time Frame:
Baseline and 6 weeks post-op
Safety Issue:
No
Principal Investigator
John Williams
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Nottingham
Authority:
United Kingdom: Research Ethics Committee
Study ID:
11005
NCT ID:
NCT01320319
Start Date:
March 2011
Completion Date:
March 2013
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
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