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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00899353
Recruitment Status : Terminated (Original Principal Investigator left the institution.)
First Posted : May 12, 2009
Results First Posted : November 18, 2013
Last Update Posted : December 12, 2013
Edwards Foundation, Inc.
Information provided by (Responsible Party):
W. Elaine Hardman, Ph.D., Marshall University

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.

Condition or disease Intervention/treatment Phase
Monoclonal Gammopathy of Undetermined Significance Smoldering Multiple Myeloma Chronic Lymphocytic Leukemia Dietary Supplement: Omega 3 Fatty Acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies
Study Start Date : August 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : October 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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) ]
    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.

  2. 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 ]

    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00899353

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United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
Marshall University
Edwards Foundation, Inc.
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Principal Investigator: Wanda E Hardman, Ph.D. Professor Marshall University School of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: W. Elaine Hardman, Ph.D., W. Elaine Hardman, Ph.D., Marshall University School of Medicine, Professor of Biochemistry and Microbiology, Marshall University Identifier: NCT00899353    
Other Study ID Numbers: MU9230
First Posted: May 12, 2009    Key Record Dates
Results First Posted: November 18, 2013
Last Update Posted: December 12, 2013
Last Verified: November 2013
Keywords provided by W. Elaine Hardman, Ph.D., Marshall University:
Early Stage - Chronic Lymphocytic Leukemia
Additional relevant MeSH terms:
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Multiple Myeloma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Smoldering Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Disease Progression
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Leukemia, B-Cell
Disease Attributes
Pathologic Processes
Precancerous Conditions