Clinical trial NCT00899353: Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)
Official title: Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Chronic Lymphocytic Leukemia
Keywords: ES-CLL
MGUS
SMM
Early Stage - Chronic Lymphocytic Leukemia
Lead sponsor: Marshall University
Sponsor class: OTHER
Collaborators: name: Edwards Foundation, Inc.
First posted: 2009-05-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.
timeFrame: baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)
measure: The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.
timeFrame: Baseline, month 1, month 2, month 3, month 6, month 9, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Edwards Comprehensive Cancer Center
state: West Virginia
Study officials:
affiliation: Professor Marshall University School of Medicine
name: Wanda E Hardman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witte TR, Salazar AJ, Ballester OF, Hardman WE. RBC and WBC fatty acid composition following consumption of an omega 3 supplement: lessons for future clinical trials. Lipids Health Dis. 2010 Mar 22;9:31. doi: 10.1186/1476-511X-9-31.