Back to resultsPrevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)
Primary Purpose
Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Chronic Lymphocytic Leukemia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omega 3 Fatty Acid
Sponsored by
About this trial
This is an interventional treatment trial for Monoclonal Gammopathy of Undetermined Significance focused on measuring ES-CLL, MGUS, SMM, Early Stage - Chronic Lymphocytic Leukemia
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.
Sites / Locations
- Edwards Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Omega 3 supplement
Arm Description
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
Outcomes
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00899353
First Posted
May 8, 2009
Last Updated
November 18, 2013
Sponsor
Marshall University
Collaborators
Edwards Foundation, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00899353
Brief Title
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
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Original Principal Investigator left the institution.
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marshall University
Collaborators
Edwards Foundation, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Chronic Lymphocytic Leukemia
Keywords
ES-CLL, MGUS, SMM, Early Stage - Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega 3 supplement
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Omega 3 Fatty Acid
Other Intervention Name(s)
Res-Q® 1250
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
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)
Title
The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.
Description
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.
Time Frame
Baseline, month 1, month 2, month 3, month 6, month 9, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanda E Hardman, Ph.D.
Organizational Affiliation
Professor Marshall University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edwards Comprehensive Cancer Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20307284
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.
Results Reference
derived
Learn more about this trial
Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)
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