Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00899353 · OUTCOME

The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.

Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM) · Source last updated 2013-12-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Fold Change
Interval / dispersion
Not reported
Time frame
Baseline, month 1, month 2, month 3, month 6, month 9, 12 months

What was measured

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.

Analysis population: 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.

Groups in this outcome

Fold Change in ALC-Patient 1

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 2

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 3

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 4

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 5

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 6

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 7

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 8

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 9

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 10

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 11

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 13

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Fold Change in ALC-Patient 14

Fold change in ALC after omega-3 consumption as compared to baseline ALC.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Fold Change in ALC-Patient 11
Fold Change in ALC-Patient 21
Fold Change in ALC-Patient 31
Fold Change in ALC-Patient 41
Fold Change in ALC-Patient 51
Fold Change in ALC-Patient 61
Fold Change in ALC-Patient 71
Fold Change in ALC-Patient 81
Fold Change in ALC-Patient 91
Fold Change in ALC-Patient 101
Fold Change in ALC-Patient 111
Fold Change in ALC-Patient 131
Fold Change in ALC-Patient 141

Reported measurements

Source class 1
Values in Fold Change · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fold Change in ALC-Patient 11.62Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 21.71Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 30.78Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 40.96Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 51.32Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 61.08Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 71.00Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 80.92Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 91.49Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 101.05Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 111.16Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 131.03Not reportedNot reportedNot reportedNot reported
Fold Change in ALC-Patient 141.22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.62
      2. group Id
        OG001
        value
        1.71
      3. group Id
        OG002
        value
        0.78
      4. group Id
        OG003
        value
        0.96
      5. group Id
        OG004
        value
        1.32
      6. group Id
        OG005
        value
        1.08
      7. group Id
        OG006
        value
        1.00
      8. group Id
        OG007
        value
        0.92
      9. group Id
        OG008
        value
        1.49
      10. group Id
        OG009
        value
        1.05
      11. group Id
        OG010
        value
        1.16
      12. group Id
        OG011
        value
        1.03
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      1
    8. group Id
      OG007
      value
      1
    9. group Id
      OG008
      value
      1
    10. group Id
      OG009
      value
      1
    11. group Id
      OG010
      value
      1
    12. group Id
      OG011
      value
      1
    units
    Participants
description
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.
groups
  1. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG000
    title
    Fold Change in ALC-Patient 1
  2. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG001
    title
    Fold Change in ALC-Patient 2
  3. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG002
    title
    Fold Change in ALC-Patient 3
  4. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG003
    title
    Fold Change in ALC-Patient 4
  5. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG004
    title
    Fold Change in ALC-Patient 5
  6. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG005
    title
    Fold Change in ALC-Patient 6
  7. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG006
    title
    Fold Change in ALC-Patient 7
  8. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG007
    title
    Fold Change in ALC-Patient 8
  9. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG008
    title
    Fold Change in ALC-Patient 9
  10. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG009
    title
    Fold Change in ALC-Patient 10
  11. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG010
    title
    Fold Change in ALC-Patient 11
  12. description
    Fold change in ALC after omega-3 consumption as compared to baseline ALC.
    id
    OG011
    title
    Fold Change in ALC-Patient 13
param Type
NUMBER
population Description
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.
reporting Status
POSTED
time Frame
Baseline, month 1, month 2, month 3, month 6, month 9, 12 months
title
The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.
type
PRIMARY
unit Of Measure
Fold Change

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice