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NCT00365768 · FLOW

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Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors · Source last updated 2016-09-09

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

groups
  1. description
    Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. Glutamine: Administered orally twice daily for 21 days
    id
    FG000
    title
    Arm I: Glutamine
  2. description
    Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21. Placebo: Administered orally twice daily for 21 days
    id
    FG001
    title
    Arm II: Placebo
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        25
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Fifty-six patients were enrolled and 49 were evaluable, with the reasons for removal from study after randomization due to: change in clinical status (N=3), family withdrew (N=2), family relocation (N=1) and other (N=1). 49 patients were randomized to the glutamine or placebo arm.
recruitment Details
All subjects were consented according to Institutional Review Board approved guidelines during out routine outpatient or inpatient stay. The period of recruitment was from January 2007 to July 2011.
Complete source fields
groups
  1. description
    Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. Glutamine: Administered orally twice daily for 21 days
    id
    FG000
    title
    Arm I: Glutamine
  2. description
    Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21. Placebo: Administered orally twice daily for 21 days
    id
    FG001
    title
    Arm II: Placebo
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        25
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Fifty-six patients were enrolled and 49 were evaluable, with the reasons for removal from study after randomization due to: change in clinical status (N=3), family withdrew (N=2), family relocation (N=1) and other (N=1). 49 patients were randomized to the glutamine or placebo arm.
recruitment Details
All subjects were consented according to Institutional Review Board approved guidelines during out routine outpatient or inpatient stay. The period of recruitment was from January 2007 to July 2011.

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Preserved source evidence · Not medical advice