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NCT01783522 · OUTCOME

Average Change in Quality of Life Scores From Baseline to End of Study

Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib · Source last updated 2019-10-22

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
from baseline to end of study at 4 months

What was measured

Quality of life will be measured on the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) including 26 summed items (responses 0 to 4 to equal a possible total score 0-108). Higher scores represent better quality of life. Average change in Quality of Life scores from baseline to end of study will be reported for each separate arm

Analysis population: All participants enrolled in study and given treatment.

Groups in this outcome

Arm I (Preventative Nutritional Supplementation)

Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months. quality-of-life assessment: Ancillary studies

Arm II (Placebo)

Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. quality-of-life assessment: Ancillary studies placebo: Given PO

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 (Preventative Nutritional Supplementation)4
Arm II (Placebo)5

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I (Preventative Nutritional Supplementation)-7.54.4Not reportedNot reportedNot reported
Arm II (Placebo)3.411.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.4
        value
        -7.5
      2. group Id
        OG001
        spread
        11.0
        value
        3.4
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Quality of life will be measured on the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) including 26 summed items (responses 0 to 4 to equal a possible total score 0-108). Higher scores represent better quality of life. Average change in Quality of Life scores from baseline to end of study will be reported for each separate arm
dispersion Type
Standard Deviation
groups
  1. description
    Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. glutamine: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months. quality-of-life assessment: Ancillary studies
    id
    OG000
    title
    Arm I (Preventative Nutritional Supplementation)
  2. description
    Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. quality-of-life assessment: Ancillary studies placebo: Given PO
    id
    OG001
    title
    Arm II (Placebo)
param Type
MEAN
population Description
All participants enrolled in study and given treatment.
reporting Status
POSTED
time Frame
from baseline to end of study at 4 months
title
Average Change in Quality of Life Scores From Baseline to End of Study
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice