Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)
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.
Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Chronic Lymphocytic Leukemia
Dietary Supplement: Omega 3 Fatty Acid
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies|
- 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. [ Time Frame: 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) ] [ Designated as safety issue: No ]Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.
- The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity. [ Time Frame: Baseline, month 1, month 2, month 3, month 6, month 9, 12 months ] [ Designated as safety issue: No ]
Patients diagnosed with early stage (asymptomatic) CLL were supplemented with escalating doses of omega-3 (n-3) fatty acids (2.4 g of n-3/day up to 7.2 g of n-3/day). Given that these patients are asymptomatic and did not require treatment, measures of tumor mass during and after omega-3 supplementation, as evaluated by standard clinical tests of disease activity, were not performed. Instead, absolute lymphocyte counts (ALC), as a measure of tumor burden, was evaluated before and after omega-3 supplementation. Data represents the fold change in ALC post omega-3 consumption as compared to baseline ALC.
Patients with MGUS or SMM were not enrolled into this study.
|Study Start Date:||August 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Omega 3 supplement
Omega 3 supplement will be added to diet, 3 capsules per day for one month then 6 capsules per day for one month then 9 capsules per day as tolerated
Dietary Supplement: Omega 3 Fatty Acid
Omega 3 supplementation will be initiated at three 1250 mg capsules daily for the first month. If dose is well tolerated, it will be increased to six 1250 mg capsules daily for 30 days, and finally to nine 1250 mg capsules daily. Treatment period is 12 months.
Other Name: Res-Q® 1250
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899353
|United States, West Virginia|
|Edwards Comprehensive Cancer Center|
|Huntington, West Virginia, United States, 25701|
|Principal Investigator:||Wanda E Hardman, Ph.D.||Professor Marshall University School of Medicine|