Effect of EPA on Aerobic Performance, Muscle, and Quality of Life in Colorectal Cancer Surgery Patients
NCT ID: NCT01320319
Last Updated: 2012-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
70 participants
INTERVENTIONAL
2011-03-31
2013-03-31
Brief Summary
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The secondary aim is to evaluate aerobic performance assessed by cardiopulmonary exercise testing (CPEX) and perioperative outcome in patients with colorectal cancer post surgical resection.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Placebo
Placebo
Capsule form, 960 mg to be taken three times a day.
Nutritional Supplementation with EPA
This arm will receive the nutritional supplementation of EPA 960mg Three times a day.
Experimental: Nutritional Supplementation with EPA
Capsule form, EPA, 960mg to be taken three times a day.
Interventions
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Placebo
Capsule form, 960 mg to be taken three times a day.
Experimental: Nutritional Supplementation with EPA
Capsule form, EPA, 960mg to be taken three times a day.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 - 85 years old.
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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John Williams
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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School of Graduate Entry Medicine & Health, Royal Derby Hospital
Derby, Derby, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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John Williams, MD, FRCA
Role: primary
References
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Hossain T, Phillips BE, Doleman B, Lund JN, Williams JP. A double-blind randomized controlled trial of the effects of eicosapentaenoic acid supplementation on muscle inflammation and physical function in patients undergoing colorectal cancer resection. Clin Nutr. 2020 Jul;39(7):2055-2061. doi: 10.1016/j.clnu.2019.09.009. Epub 2019 Oct 11.
Other Identifiers
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11005
Identifier Type: -
Identifier Source: org_study_id