Clinical trial · Interventional
Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)
Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Original Principal Investigator left the institution.
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Monoclonal Gammopathy of Undetermined Significance | Monoclonal Gammopathy of Undetermined Significance | ONTOLOGY_EXACT | 0.98 |
| Smoldering Multiple Myeloma | Smoldering Multiple Myeloma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omega 3 Fatty Acid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omega 3 supplement
- 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
- interventionNames
- Dietary Supplement: Omega 3 Fatty Acid
Primary outcomes (2)
- measure
- 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.
- timeFrame
- 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)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWitte 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