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Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors

2014-08-27 03:17:17 | BioPortfolio

Summary

RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with cancer receiving radiation therapy to the brain.

PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue caused by radiation therapy in patients with primary brain tumors.

Description

OBJECTIVES:

Primary

- To estimate study accrual, adherence, retention, and participation of patients with primary brain tumors undergoing partial- or whole-brain radiotherapy who are randomized to receive armodafinil or placebo.

- To estimate the variability of fatigue, quality of life, and neurocognitive function in these patients.

Secondary

- To obtain a preliminary estimate of the effect of armodafinil on fatigue as measured by the fatigue subscale of the FACIT-F and the Brief Fatigue Inventory.

- To estimate the rates of toxicity and adverse events associated with armodafinil.

- To obtain preliminary estimates of the effect of armodafinil on sleepiness as measured by the Epworth Sleep Scale; overall quality of life and brain-specific quality of life as measured by the FACT-G with the brain subscale; and cognitive function as measured by a comprehensive Wake Forest Cognitive Function Battery.

OUTLINE: This is a multicenter study. Patients are stratified according to therapy (radiotherapy alone vs radiotherapy and chemotherapy) and Karnofsky performance status (60-80% vs 90-100%). Patients are randomized to 1 of 2 arms.

- Arm I: 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.

- Arm II: 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.

Patients complete questionnaires assessing fatigue, quality of life, and neurocognitive function at baseline and periodically during study.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Conditions

Brain Tumors

Intervention

Armodafinil, placebo

Location

Wake Forest University Comprehensive Cancer Center
Winston-Salem
North Carolina
United States
27157-1096

Status

Completed

Source

Wake Forest Cancer Center CCOP Research Base

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:17-0400

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