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

This study has been terminated.
(Original Principal Investigator left the institution.)
Sponsor:
Collaborator:
Edwards Foundation, Inc.
Information provided by (Responsible Party):
W. Elaine Hardman, Ph.D., Marshall University
ClinicalTrials.gov Identifier:
NCT00899353
First received: May 8, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Marshall University:

Primary Outcome Measures:
  • 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.



Enrollment: 16
Study Start Date: August 2008
Study Completion Date: October 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899353

Locations
United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
Marshall University
Edwards Foundation, Inc.
Investigators
Principal Investigator: Wanda E Hardman, Ph.D. Professor Marshall University School of Medicine
  More Information

No publications provided by Marshall University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: W. Elaine Hardman, Ph.D., W. Elaine Hardman, Ph.D., Marshall University School of Medicine, Professor of Biochemistry and Microbiology, Marshall University
ClinicalTrials.gov Identifier: NCT00899353     History of Changes
Other Study ID Numbers: MU9230
Study First Received: May 8, 2009
Results First Received: April 29, 2013
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Marshall University:
ES-CLL
MGUS
SMM
Early Stage - Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Multiple Myeloma
Neoplasms, Plasma Cell
Disease Progression
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014