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Effect of EPA on Aerobic Performance, Muscle, and Quality of Life in Colorectal Cancer Surgery Patients (EPA-colo)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Nottingham
Sponsor:
Collaborator:
Derby Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01320319
First received: March 2, 2011
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

Primary Aim is to test the Hypothesis: Nutritional supplementation with 960mg EPA three times a day positively affects muscle function and mass (assessed by muscle biopsies, assays of cellular aerobic function and DEXA scan) and inflammation (measuring cellular markers of inflammation) in patients undergoing resection of colorectal cancers.

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.


Condition Intervention Phase
Colorectal Cancer
Other: Placebo
Dietary Supplement: Experimental: Nutritional Supplementation with EPA
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Nutritional supplementation with 960mg EPA three times a day positively affects muscle function and mass [ Time Frame: Baseline and 6 weeks post-op ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • The secondary aim is to look at the aerobic performance. [ Time Frame: Baseline and 5 weeks post-op. ] [ Designated as safety issue: No ]
    The secondary aim is to look at the aerobic performance assessed by cardiopulmonary exercise testing (CPEX) and perioperative outcome in patients with colorectal cancer post surgical resection.


Estimated Enrollment: 70
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Capsule form, 960 mg to be taken three times a day.
Experimental: Nutritional Supplementation with EPA
This arm will receive the nutritional supplementation of EPA 960mg Three times a day.
Dietary Supplement: Experimental: Nutritional Supplementation with EPA
Capsule form, EPA, 960mg to be taken three times a day.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320319

Contacts
Contact: John Williams, MD, FRCS +44 1332 785566 john.williams7@nhs.net
Contact: Tanvir Hossain, MBCHB, MRCS +44 7791007989 tanvir.hossain@nhs.net

Locations
United Kingdom
School of Graduate Entry Medicine & Health, Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3DT
Contact: John Williams, MD, FRCA    +44 1332 785566    john.williams7@nhs.net   
Principal Investigator: John Williams, MD, FRCA         
Sub-Investigator: Tanvir Hossain, MbCHB, MRCS         
Sponsors and Collaborators
University of Nottingham
Derby Hospitals NHS Foundation Trust
Investigators
Principal Investigator: John Williams University of Nottingham
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01320319     History of Changes
Other Study ID Numbers: 11005
Study First Received: March 2, 2011
Last Updated: December 3, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014