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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00815685
First received: December 29, 2008
Last updated: December 13, 2013
Last verified: December 2013

December 29, 2008
December 13, 2013
July 2007
March 2010   (final data collection date for primary outcome measure)
Change in Serum Albumin [ Time Frame: 6 weeks per patient ] [ Designated as safety issue: No ]
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.
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 ]
Complete list of historical versions of study NCT00815685 on ClinicalTrials.gov Archive Site
Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%. [ Time Frame: 6 weeks per patient ] [ Designated as safety issue: No ]
There is no expected range for "normal" activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA.
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 ]
Not Provided
Not Provided
 
A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia
A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer Cachexia
Drug: Eicosapentaenoic Acid
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.
Other Names:
  • Lovaza
  • EPA
  • omega-3-acid ethyl esters
  • docosahexaenoic acid
  • DHA
Experimental: Eicosapentaenoic Acid
Intervention: Drug: Eicosapentaenoic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2010
March 2010   (final data collection date for primary outcome measure)

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 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.

Exclusion Criteria:

  • 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
Both
25 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00815685
MCC-15190
No
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
GlaxoSmithKline
Principal Investigator: Nagi Kumar, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP