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

NCT00899353 | Terminated Phase 2 Results

• 1 other identifier: MU9230
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoldering Multiple Myeloma; Chronic Lymphocytic Leukemia; Monoclonal Gammopathy of Undetermined Significance

Keywords

ES-CLL; MGUS; SMM; Early Stage - Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (2)

• 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)

• 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

Study Arms (1)

Omega 3 supplement

EXPERIMENTAL

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

Interventions

Omega 3 Fatty Acid DIETARY_SUPPLEMENT

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.

Also known as: Res-Q® 1250

Omega 3 supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marshall University: lead
• Edwards Foundation, Inc.: collaborator

Study Sites (1)

Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701, United States

Location

Related Publications (1)

• 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.

  PMID: 20307284 DERIVED

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Neoplasms; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Dr. W. Elaine Hardman
• Organization: Marshall University Joan C. Edwards School of Medicine

hardmanw@marshall.edu

304-696-3721

Study Officials

• Wanda E Hardman, Ph.D.

  Professor Marshall University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: W. Elaine Hardman, Ph.D., Marshall University School of Medicine, Professor of Biochemistry and Microbiology

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 12, 2009
• Study Start: August 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: October 1, 2012
• Last Updated: December 12, 2013
• Results First Posted: November 18, 2013

Record last verified: 2013-11

Locations

US (1)