A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia

NCT00815685 | Completed Results

• 1 other identifier: MCC-15190
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

The data collected through this pilot study will allow us to increase our understanding of cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our long-term goal is to improve nutritional treatment and reduce illness in the cancer patient population.

Conditions

Cancer Cachexia

Keywords

n-3 fatty acids; nutritional treatment; molecular pathogenesis

Outcome Measures

Primary Outcomes (1)

• Change in Serum Albumin

  Change in protein status at 6 weeks after initial diagnosis of weight loss of \>5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.

  6 weeks per patient

Secondary Outcomes (1)

• Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%.

  6 weeks per patient

Study Arms (1)

Eicosapentaenoic Acid

EXPERIMENTAL

Drug: Eicosapentaenoic Acid

Interventions

Eicosapentaenoic Acid DRUG

Participants will receive Lovaza at a dose of 4 g for 6 weeks. Participants will be examined at six weeks for change in protein status as indicated by change in morphological (Height, weight, body mass index, body composition, lean body mass, body fat %), and biochemical (serum prealbumin) markers of protein status and immunological cytokines (Il-6, TNF- α) markers implicated in cancer cachexia. At baseline, 3 and 6 weeks, participants will undergo interviews and laboratory analysis for determining compliance and treatment-related toxicity.

Also known as: Lovaza, EPA, omega-3-acid ethyl esters, docosahexaenoic acid, DHA

Eicosapentaenoic Acid

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women 25-80 years of age (inclusive)
• Confirmed diagnosis of Cancer (other than pancreatic cancer) Unintentional weight loss of \>5% of body weight within 3 months of admission to the study
• Use of effective means of contraception (men and women) in patients of child-bearing potential
• Normal baseline liver function tests (LFTs) as determined by alanine aminotransferase (ALT) levels. Common Toxicity Criteria (CTC)) version 3 grade 1 elevation in ALT (\>Upper Limit of Normal\[UNL\]-2.5 x UNL) withhold admitting participant to the study until recovery to normal; LFTs will be considered valid for consideration of eligibility if drawn within the previous 2 weeks, otherwise new labs will be drawn.
• Able and willing to give written informed consent : Each participant must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 (Karnofsky score \>60%)
• Concurrent use of coumadin or warfarin is okay. The follow-up monitoring for prothrombin (PT), partial thromboplastin time (PTT) and International Normalized Ratio (INR) for patients on warfarin and/or coumadin will follow the standard of care as dictated by the prescribing physician. If the prescribing physician is not a Moffitt physician, then the prescribing physician will be notified by the research staff of the subject participating in the study, and monitors for PT, PTT and INR will be obtained from patient during the 6 week study for review.

You may not qualify if:

• Patients with current diagnosis or history of pancreatic cancer
• Current use of anticoagulants other than coumadin, warfarin, or aspirin
• Use of other nutritional supplements other than multivitamins and minerals
• Allergy to fish or seafood
• Using Marinol or Megace
• Known history of hepatic or renal disease
• Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
• Evidence of bleeding diathesis or coagulopathy
• Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
• Pregnant (positive pregnancy test) or lactating

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

Martin Memorial

Stuart, Florida, 34997, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Interventions

Eicosapentaenoic Acid; Omacor; Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Limitations and Caveats

This was a Pilot Supportive Care Intervention.

Results Point of Contact

• Title: Nagi Kumar, Ph.D., via Moffitt Cancer Center
• Organization: H. Lee Moffitt Cancer Center and Research Institute

nagi.kumar@moffitt.org

813-745-6885

Study Officials

• Nagi Kumar, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 30, 2008
• Study Start: July 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 23, 2017
• Results First Posted: September 8, 2011

Record last verified: 2013-12

Locations

US (2)