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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00899353
• Other study ID #: MU9230
• Status: Terminated
• Phase: Phase 2
• First received: May 8, 2009
• Last updated: November 18, 2013
• Start date: August 2008
• Est. completion date: October 2012

Study information

• Verified date: November 2013
• Source: Marshall University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Disease Progression
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Monoclonal Gammopathy of Undetermined Significance
• Multiple Myeloma
• Paraproteinemias
• Smoldering Multiple Myeloma

Intervention

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.

Locations

Country	Name	City	State
United States	Edwards Comprehensive Cancer Center	Huntington	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Marshall University	Edwards Foundation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)	No
Primary	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.	Baseline, month 1, month 2, month 3, month 6, month 9, 12 months	No