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


N/A
25 Years
80 Years
Not Enrolling
Both
Cancer Cachexia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in Serum Albumin

Outcome Description:

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.

Outcome Time Frame:

6 weeks per patient

Safety Issue:

No

Principal Investigator

Nagi Kumar, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-15190

NCT ID:

NCT00815685

Start Date:

July 2007

Completion Date:

August 2010

Related Keywords:

  • Cancer Cachexia
  • n-3 fatty acids
  • nutritional treatment
  • molecular pathogenesis
  • Cachexia

Name

Location

H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Martin MemorialStuart, Florida  34994