Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)

Stopped early · Phase 2

Conditions studied: Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Chronic Lymphocytic Leukemia

In brief

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 Multiple Myeloma (SMM), whose disease does not currently require treatment. The primary aim of the study is to determine if the Omega 3 supplementation will help prevent or delay progression of the disease to a stage that requires treatment.

Key facts

Study ID: NCT00899353
Run by: Marshall University
People needed: 16
Starts: 2008-08-01
Expected to finish: 2012-10-01
Last updated by the study team: 2013-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Edwards Comprehensive Cancer Center — Huntington, West Virginia, United States

Full record on ClinicalTrials.gov

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