A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia - Full Text View

Sponsors and Collaborators:	H. Lee Moffitt Cancer Center and Research Institute GlaxoSmithKline
Information provided by:	H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:	NCT00815685

Purpose

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

Condition	Intervention	Phase
Cancer Cachexia	Drug: Eicosapentaenoic Acid	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Omacor Docosahexaenoic acids Eicosapentaenoic acid BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:

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. Treatment Toxicity associated with this regimen. [ Time Frame: 6 weeks per patient ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To explore the fundamental molecular pathways of Lovaza as indicated by observing changes in levels of proteasome activity (IkB-α protein expression, and NFkB DNA-binding activity) in serum. [ Time Frame: 6 weeks per patient ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	July 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Eicosapentaenoic Acid Subjects recruited will receive Lovaza at a dose of 4 g for 6 weeks. Subjects 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.

Arms

Assigned Interventions

1: Experimental

Drug: Eicosapentaenoic Acid

Subjects recruited will receive Lovaza at a dose of 4 g for 6 weeks. Subjects 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.

Detailed Description:

People who have cancer can get what is called cancer cachexia (CC). The symptoms of CC include getting full quickly when eating (early satiety), loss of appetite, weakness resulting in weight loss and loss of lean body mass. Even a weight loss of 5% in cancer patients reflects poor health, hospitalization, and a higher rate of illness. Research shows that the elderly are at higher risk for deficiency of vitamins and trace minerals. Other pre-existing chronic diseases and drug therapies in this population may increase the needs of certain nutrients. Recent studies have also shown that advanced malnutrition is much more difficult to treat in the elderly than in younger adults, and the consequences of failure to treat it delays recovery and can decrease function and quality of life. At this time, the ways to treat CC include giving medications to increase appetite and giving nutritional supplements that are high in calories and protein.

Recent studies have shown that certain types of fats that are present in fish, walnuts and other foods that we eat called Eicosapentaenoic acid (EPA) may help with weight gain, especially gain in muscle and improve quality of life in patients with pancreatic cancer. However, EPA has never been studied in prevention of cancer cachexia in cancer patients showing early signs of weight loss. Based on these early, small studies, it is clear that we need to study if and how EPA can prevent loss of muscle and weight in cancer patients and prevent this from becoming worse.

Eligibility

Ages Eligible for Study:	25 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 subjects of child-bearing potential
Normal baseline liver function tests as determined by ALT levels. NCI CTC version 3 grade 1 elevation in ALT (>UNL-2.5 x UNL) withhold admitting subject 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 subject 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.
ECOG performance status of 0- 2 (Karnofsky score >60%)
Concurrent use of coumadin or warfarin okay The follow-up monitoring for PT, PTT and 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 MD , then the prescribing MD 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.

Exclusion Criteria:

Subjects 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 subject 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 subject inappropriate for entry into this study
Pregnant (positive pregnancy test) or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815685

Locations

United States, Florida
H. Lee Moffitt Cancer Center & Research Institute	Recruiting
Tampa, Florida, United States, 33612
Contact: Tiffany Smith 813-745-6250 tiffany.smith@moffitt.org
Principal Investigator: Nagi Kumar, PhD RD FADA
Sub-Investigator: Eduardo Sotomayor, M.D.
Sub-Investigator: Lodovicco Balducci, M.D.
Sub-Investigator: Martine Extermann, M.D.
Sub-Investigator: Sikumar Chellappan, Ph.D.
Sub-Investigator: Gerold Bepler, M.D., Ph.D.
Martin Memorial	Recruiting
Stuart, Florida, United States, 34997
Contact: Wendy Ryzner, RN 772-223-5945 wryzner@mmhs-fla.org
Principal Investigator: Kiran Reddy, M.D.

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

GlaxoSmithKline

Investigators

Principal Investigator:

Nagi Kumar, Ph.D.

H. Lee Moffitt Cancer Center and Research Institute

More Information

Moffitt Cancer Center Clinical Trials website This link exits the ClinicalTrials.gov site

Responsible Party:	H. Lee Moffitt Cancer Center & Research Institute ( Nagi Kumar, Ph.D., RD. FADA )
Study ID Numbers:	MCC-15190, IRB 105759c
Study First Received:	December 29, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00815685
Health Authority:	United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:

n-3 fatty acids
nutritional treatment
molecular pathogenesis

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Weight Loss

Body Weight Changes
Cachexia
Emaciation

ClinicalTrials.gov processed this record on January 15, 2009