Trial Outcomes & Findings for Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM) (NCT NCT00899353)
NCT ID: NCT00899353
Last Updated: 2013-12-12
Results Overview
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.
TERMINATED
PHASE2
16 participants
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)
2013-12-12
Participant Flow
Participant milestones
| Measure |
Omega 3 Supplementation
Baseline blood specimens were obtained. All participants were then assigned to consume three, 1250mg omega 3 supplement capsules per day (providing 2.4g of omega 3 total) for one month, the first period. Blood was obtained and participants were assigned to consume six, 1250mg capsules of omega 3 per day (providing 4.8g of omega 3)for one month, the second period. Blood was again obtained and participants were assigned to consume 9 capsules of omega 3 per day, providing 7.2g of omega 3,the third period.
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
| Measure |
Omega 3 Supplementation
Baseline blood specimens were obtained. All participants were then assigned to consume three, 1250mg omega 3 supplement capsules per day (providing 2.4g of omega 3 total) for one month, the first period. Blood was obtained and participants were assigned to consume six, 1250mg capsules of omega 3 per day (providing 4.8g of omega 3)for one month, the second period. Blood was again obtained and participants were assigned to consume 9 capsules of omega 3 per day, providing 7.2g of omega 3,the third period.
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|---|---|
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Overall Study
Adverse Event
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2
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Overall Study
Lost to Follow-up
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1
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)
Baseline characteristics by cohort
| Measure |
Omega 3 Supplementation
n=16 Participants
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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6 Participants
n=5 Participants
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Age, Categorical
>=65 years
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10 Participants
n=5 Participants
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Age Continuous
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68 years
STANDARD_DEVIATION 7 • n=5 Participants
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Sex: Female, Male
Female
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9 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Region of Enrollment
United States
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16 participants
n=5 Participants
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PRIMARY outcome
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)Population: NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (\> median, n=7) and low initial baseline (\< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods
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.
Outcome measures
| Measure |
Baseline Nuclear Factor Kappa B Activation
n=15 Participants
Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.
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Nuclear Factor Kappa B Activation Following 3 Capsules Per Day
n=12 Participants
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
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Nuclear Factor Kappa B Activation Following 6 Capsules Per Day
n=12 Participants
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.
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Nuclear Factor Kappa B Activation Following 9 Capsules Per Day
n=10 Participants
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
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Nuclear Factor Kappa B Activation Post Supplement
n=8 Participants
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.
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Fold Change in ALC-Patient 6
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 7
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 8
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 9
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 10
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 11
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 13
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 14
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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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.
Total Population
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7.2 10^6 NFkB Luminescence units/µg protein
Standard Error 2.25 • Interval 0.945 to 231.0
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4.1 10^6 NFkB Luminescence units/µg protein
Standard Error 1.53
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4.2 10^6 NFkB Luminescence units/µg protein
Standard Error 1.15
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0.7 10^6 NFkB Luminescence units/µg protein
Standard Error 0.94
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1.5 10^6 NFkB Luminescence units/µg protein
Standard Error 0.86
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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.
Higher Initial Expressers
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12.8 10^6 NFkB Luminescence units/µg protein
Standard Error 2.77
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7.4 10^6 NFkB Luminescence units/µg protein
Standard Error 2.41
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6.4 10^6 NFkB Luminescence units/µg protein
Standard Error 1.42
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0.8 10^6 NFkB Luminescence units/µg protein
Standard Error 0.20
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1.6 10^6 NFkB Luminescence units/µg protein
Standard Error 1.44
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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.
Lower Initial Expressers
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0.8 10^6 NFkB Luminescence units/µg protein
Standard Error 0.27
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0.9 10^6 NFkB Luminescence units/µg protein
Standard Error 0.37
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1.5 10^6 NFkB Luminescence units/µg protein
Standard Error 0.80
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0.6 10^6 NFkB Luminescence units/µg protein
Standard Error 0.11
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1.3 10^6 NFkB Luminescence units/µg protein
Standard Error 1.16
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PRIMARY outcome
Timeframe: Baseline, month 1, month 2, month 3, month 6, month 9, 12 monthsPopulation: Patients who's absolute lymphocyte counts were known prior to omega-3 initiation (baseline) and after omega-3 consumption were included in this analysis. Patients who's ALC was unknown prior to omega-3 initiation or after omega-3 consumption were excluded.
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.
Outcome measures
| Measure |
Baseline Nuclear Factor Kappa B Activation
n=1 Participants
Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.
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Nuclear Factor Kappa B Activation Following 3 Capsules Per Day
n=1 Participants
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
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Nuclear Factor Kappa B Activation Following 6 Capsules Per Day
n=1 Participants
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.
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Nuclear Factor Kappa B Activation Following 9 Capsules Per Day
n=1 Participants
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
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Nuclear Factor Kappa B Activation Post Supplement
n=1 Participants
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.
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Fold Change in ALC-Patient 6
n=1 Participants
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 7
n=1 Participants
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 8
n=1 Participants
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 9
n=1 Participants
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 10
n=1 Participants
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 11
n=1 Participants
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 13
n=1 Participants
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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Fold Change in ALC-Patient 14
n=1 Participants
Fold change in ALC after omega-3 consumption as compared to baseline ALC.
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The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.
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1.62 Fold Change
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1.71 Fold Change
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0.78 Fold Change
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0.96 Fold Change
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1.32 Fold Change
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1.08 Fold Change
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1.00 Fold Change
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0.92 Fold Change
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1.49 Fold Change
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1.05 Fold Change
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1.16 Fold Change
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1.03 Fold Change
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1.22 Fold Change
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Adverse Events
Adverse Effects
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adverse Effects
n=16 participants at risk
Serious adverse effects associated with omega 3 fatty acid consumption.
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|---|---|
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Gastrointestinal disorders
Diarrhea
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25.0%
4/16 • Number of events 5
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General disorders
Nausea
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12.5%
2/16 • Number of events 3
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Additional Information
Dr. W. Elaine Hardman
Marshall University Joan C. Edwards School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place