A Phase 2 interventional study of Omega 3 Fatty Acid in Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma and Chronic Lymphocytic Leukemia, sponsored by Marshall University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-12.
Sponsored by Marshall University · Phase 2, Interventional, and Treatment
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 16 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Marshall University is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
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
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.
Time frame: 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.
Time frame: Baseline, month 1, month 2, month 3, month 6, month 9, 12 months
| Milestone | Omega 3 Supplementation |
|---|---|
| Started | 16 |
| Completed | 11 |
| Not completed | 5 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 2 |
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.
| 10^6 NFkB Luminescence units/µg protein | Baseline Nuclear Factor Kappa B Activation | Nuclear Factor Kappa B Activation Following 3 Capsules Per Day | Nuclear Factor Kappa B Activation Following 6 Capsules Per Day | Nuclear Factor Kappa B Activation Following 9 Capsules Per Day | Nuclear Factor Kappa B Activation Post Supplement |
|---|---|---|---|---|---|
| Total Population | 7.2 ± 2.25 | 4.1 ± 1.53 | 4.2 ± 1.15 | 0.7 ± 0.94 | 1.5 ± 0.86 |
| Higher Initial Expressers | 12.8 ± 2.77 | 7.4 ± 2.41 | 6.4 ± 1.42 | 0.8 ± 0.20 | 1.6 ± 1.44 |
| Lower Initial Expressers | 0.8 ± 0.27 | 0.9 ± 0.37 | 1.5 ± 0.80 | 0.6 ± 0.11 | 1.3 ± 1.16 |
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.
| Fold Change | Fold Change in ALC-Patient 1 | Fold Change in ALC-Patient 2 | Fold Change in ALC-Patient 3 | Fold Change in ALC-Patient 4 | Fold Change in ALC-Patient 5 | Fold Change in ALC-Patient 6 | Fold Change in ALC-Patient 7 | Fold Change in ALC-Patient 8 | Fold Change in ALC-Patient 9 | Fold Change in ALC-Patient 10 | Fold Change in ALC-Patient 11 | Fold Change in ALC-Patient 13 | Fold Change in ALC-Patient 14 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity. | 1.62 | 1.71 | 0.78 | 0.96 | 1.32 | 1.08 | 1.00 | 0.92 | 1.49 | 1.05 | 1.16 | 1.03 | 1.22 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Effects | — | 0/16 (0%) | 5/16 (31.3%) |
| Event | Adverse Effects |
|---|---|
| DiarrheaGastrointestinal disorders | 4/16 |
| NauseaGeneral disorders | 2/16 |
| Age, Categorical(Participants) | Omega 3 Supplementation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 10 |
| Age Continuous(years) | Omega 3 Supplementation |
|---|---|
| Mean | 68 ± 7 |
| Sex: Female, Male(Participants) | Omega 3 Supplementation |
|---|---|
| Female | 9 |
| Male | 7 |
| Region of Enrollment(participants) | Omega 3 Supplementation |
|---|---|
| United States | 16 |
This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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