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

NCT ID: NCT00899353

Last Updated: 2013-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Monoclonal Gammopathy of Undetermined Significance Smoldering Multiple Myeloma Chronic Lymphocytic Leukemia

Keywords

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ES-CLL MGUS SMM Early Stage - Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Omega 3 Fatty Acid

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Res-Q® 1250

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Foundation, Inc.

OTHER

Sponsor Role collaborator

Marshall University

OTHER

Sponsor Role lead

Responsible Party

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W. Elaine Hardman, Ph.D.

W. Elaine Hardman, Ph.D., Marshall University School of Medicine, Professor of Biochemistry and Microbiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wanda E Hardman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor Marshall University School of Medicine

Locations

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Edwards Comprehensive Cancer Center

Huntington, West Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20307284 (View on PubMed)

Other Identifiers

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MU9230

Identifier Type: -

Identifier Source: org_study_id