Omega 3 Supplementation for the Prevention of Disease Progression in Early Stage Chronic Lymphocytic Leukemia (ES-CLL), Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - Full Text View

Sponsor:	Marshall University
Collaborator:	Edwards Foundation, Inc.
Information provided by:	Marshall University
ClinicalTrials.gov Identifier:	NCT00899353

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
Chronic Lymphocytic Leukemia (CLL Enrollment Maximum Has Been Met) Monoclonal Gammopathy of Undetermined Significance Smoldering Multiple Myeloma	Dietary Supplement: Omega 3 Fatty Acid	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia Multiple Myeloma

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Further study details as provided by Marshall University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Omega 3 supplementation	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 Names: Res-Q® 1250 Each capsule contains: Omega-3 Fatty Acids 750-850 mg, including EPA (Eicosapentaenoic Acid) 390-430 mg, DHA (Docosahexaenoic Acid) 300-325 mg and other Omega-3 Fatty Acids 50-100 mg

Arms

Assigned Interventions

Experimental: Omega 3 supplementation

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 Names:

Res-Q® 1250
Each capsule contains:
Omega-3 Fatty Acids 750-850 mg, including EPA (Eicosapentaenoic Acid) 390-430 mg, DHA (Docosahexaenoic Acid) 300-325 mg and other Omega-3 Fatty Acids 50-100 mg

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

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

Contacts

Contact: Leann R Ross, RN	304-399-6617	leann.ross@chhi.org
Contact: Oscar F Ballester, MD	304-399-6551	oscar.ballester@chhi.org

Locations

United States, West Virginia
Edwards Comprehensive Cancer Center	Recruiting
Huntington, West Virginia, United States, 25701
Contact: Leann R Ross, RN 304-399-6617 leann.ross@chhi.org
Contact: Barb Payne, RN 304-399-6637 barbara.payne@chhi.org
Principal Investigator: Oscar Ballester, MD

Sponsors and Collaborators

Marshall University

Edwards Foundation, Inc.

Investigators

Principal Investigator:

Oscar F Ballester, MD

Marshall University/University Oncology Services at Edwards Comprehensive Cancer Center

More Information

No publications provided by Marshall University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Oscar Ballester, MD, Marshall University
ClinicalTrials.gov Identifier:	NCT00899353 History of Changes
Other Study ID Numbers:	MU9230
Study First Received:	May 8, 2009
Last Updated:	July 29, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Marshall University:

ES-CLL
MGUS
SMM
Early Stage - Chronic Lymphocytic Leukemia (CLL cohort has been filled)

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 February 09, 2012