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

Marshall University

Status and phase

Terminated

Phase 2

Conditions

Chronic Lymphocytic Leukemia

Smoldering Multiple Myeloma

Monoclonal Gammopathy of Undetermined Significance

Treatments

Dietary Supplement: Omega 3 Fatty Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT00899353

MU9230

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.