Status:
TERMINATED
Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)
Lead Sponsor:
Marshall University
Collaborating Sponsors:
Edwards Foundation, Inc.
Conditions:
Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Escalating doses of Omega 3 Fatty Acids are being used in patients who have early stage Chronic Lymphocytic Leukemia (ES-CLL), Monoclonal Gammopathy of Undetermined Significance (MGUS), or Smoldering ...
Eligibility Criteria
Inclusion
- Must be over 18 years of age.
- Must be free of other medical conditions that would decrease life expectancy to less that 12 months.
- Must be free of Omega 3 supplements or other fish oil containing nutritional supplements for a minimum of two months prior to enrollment.
- Must have a ECOG performance status of 0,1 or 2.
Exclusion
- Any life-threatening condition such as (but not limited to) advanced heart disease, kidney or liver failure with an expected survival of less than 12 months.
- Any other active malignancy.
- Women who are pregnant or lactating.
- Individuals unable to give informed consent.
- Individuals with known allergy or intolerance to fish oil supplements.
- Any patient with an active bleeding diatheses or disorder.
- ECOG performance status of 3 or 4.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00899353
Start Date
August 1 2008
End Date
October 1 2012
Last Update
December 12 2013
Active Locations (1)
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1
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701