Effect of EPA on Aerobic Performance, Muscle, and Quality of Life in Colorectal Cancer Surgery Patients
EPA-colo
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
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 colorectal-cancer
Started Mar 2011
Shorter than P25 for phase_2 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 2, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedDecember 4, 2012
December 1, 2012
1.8 years
March 2, 2011
December 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Nutritional supplementation with 960mg EPA three times a day positively affects muscle function and mass
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).
Baseline and 6 weeks post-op
Secondary Outcomes (1)
The secondary aim is to look at the aerobic performance.
Baseline and 5 weeks post-op.
Study Arms (2)
Placebo
PLACEBO COMPARATORNutritional Supplementation with EPA
EXPERIMENTALThis arm will receive the nutritional supplementation of EPA 960mg Three times a day.
Interventions
Capsule form, EPA, 960mg to be taken three times a day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Graduate Entry Medicine & Health, Royal Derby Hospital
Derby, Derby, DE22 3DT, United Kingdom
Related Publications (1)
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.
PMID: 31648815DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Williams
University of Nottingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2011
First Posted
March 22, 2011
Study Start
March 1, 2011
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
December 4, 2012
Record last verified: 2012-12