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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
Edwards Foundation, Inc.
Information provided by (Responsible Party):
W. Elaine Hardman, Ph.D., Marshall University

Tracking Information
First Submitted Date  ICMJE May 8, 2009
First Posted Date  ICMJE May 12, 2009
Results First Submitted Date  ICMJE April 29, 2013
Results First Posted Date  ICMJE November 18, 2013
Last Update Posted Date December 12, 2013
Study Start Date  ICMJE August 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2009)
  • To determine whether consumption of Omega-3 supplement, at the defined dose, can reduce activated Nuclear Factor kappa B in peripheral blood lymphocytes from patients with MGUS and SMM and in malignant lymphocytes from patients with CLL. [ Time Frame: 12 months ]
  • To determine the incidence and degree of changes in tumor mass measurements during and after Omega-3 supplementation as evaluated by standard clinical tests of disease activity. [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)
Official Title  ICMJE Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Monoclonal Gammopathy of Undetermined Significance
  • Smoldering Multiple Myeloma
  • Chronic Lymphocytic Leukemia
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Dietary Supplement: Omega 3 Fatty Acid
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 23, 2013)
16
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2009)
48
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00899353
Other Study ID Numbers  ICMJE MU9230
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party W. Elaine Hardman, Ph.D., Marshall University
Study Sponsor  ICMJE Marshall University
Collaborators  ICMJE Edwards Foundation, Inc.
Investigators  ICMJE
Principal Investigator: Wanda E Hardman, Ph.D. Professor Marshall University School of Medicine
PRS Account Marshall University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP