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NCT01032200 · OUTCOME

Fatigue

Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors · Source last updated 2021-09-28

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

Measure
LEAST_SQUARES_MEAN
Unit
units on a scale
Interval / dispersion
Standard Error
Time frame
4 weeks post-RT

What was measured

Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. The total Score ranges from 0 to 52, with higher scores indicating less fatigue.

Analysis population: Participants with any data

Groups in this outcome

Arm I - Armodafinil

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. Armodafinil: Given orally

Arm II - Placebo

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. placebo: Given orally

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 - Armodafinil26
Arm II - Placebo27

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I - Armodafinil32.42.6Not reportedNot reportedNot reported
Arm II - Placebo36.42.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.6
        value
        32.4
      2. group Id
        OG001
        spread
        2.5
        value
        36.4
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      27
    units
    Participants
description
Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. The total Score ranges from 0 to 52, with higher scores indicating less fatigue.
dispersion Type
Standard Error
groups
  1. description
    Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. Armodafinil: Given orally
    id
    OG000
    title
    Arm I - Armodafinil
  2. description
    Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. placebo: Given orally
    id
    OG001
    title
    Arm II - Placebo
param Type
LEAST_SQUARES_MEAN
population Description
Participants with any data
reporting Status
POSTED
time Frame
4 weeks post-RT
title
Fatigue
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice