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NCT00369564 · OUTCOME

Ability to Receive All Scheduled Doses of Vincristine

Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer · Source last updated 2021-08-11

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
10 weeks

What was measured

We will determine if a greater proportion of patients receiving l-glutamic acid hydrochloride are able to receive 100% of their scheduled doses of vincristine as compared to those in the placebo control group

Analysis population: Number in stratum 1 and stratum 2 that completed

Groups in this outcome

Arm I Glutamic Acid

Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m\^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m\^2 will receive a total of 1500 mg/day of oral glutamic acid .

Arm II Placebo

Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent. Patients with a body surface area (BSA) less than 1.0 m\^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m\^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). .

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

Analysis denominator · Participants

GroupSource count
Arm I Glutamic Acid127
Arm II Placebo123

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I Glutamic Acid84Not reportedNot reportedNot reportedNot reported
Arm II Placebo100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      127
    2. group Id
      OG001
      value
      123
    units
    Participants
description
We will determine if a greater proportion of patients receiving l-glutamic acid hydrochloride are able to receive 100% of their scheduled doses of vincristine as compared to those in the placebo control group
groups
  1. description
    Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m\^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m\^2 will receive a total of 1500 mg/day of oral glutamic acid .
    id
    OG000
    title
    Arm I Glutamic Acid
  2. description
    Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent. Patients with a body surface area (BSA) less than 1.0 m\^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m\^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). .
    id
    OG001
    title
    Arm II Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
Number in stratum 1 and stratum 2 that completed
reporting Status
POSTED
time Frame
10 weeks
title
Ability to Receive All Scheduled Doses of Vincristine
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice