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

Information source: Wake Forest NCORP Research Base
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Tumors; Nervous System Tumors; Cognition Disorders; Fatigue

Intervention: Armodafinil (Drug); placebo (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Wake Forest NCORP Research Base

Official(s) and/or principal investigator(s):
Edward G. Shaw, MD, Principal Investigator, Affiliation: Comprehensive Cancer Center of Wake Forest University

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.

Clinical Details

Official title: A Feasibility Study of Armodafinil for Brain Radiation-Induced Fatigue

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

Primary outcome: Estimate accrual, adherence, retention, and participation of primary brain tumor patients undergoing partial or whole-brain RT who are randomized to receive armodafinil.

Secondary outcome:

Toxicity as measured by the CTEP active version of the CTCAE

Fatigue as measured by the FACIT-F and Brief Fatigue Inventory

Overall quality of life and brain-specific quality of life

Sleepiness as measured by the Epworth Sleep Scale

Cognitive function as measured by the Wake Forest Cognitive Function Battery

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed primary brain tumor, including any of the following:

- Glioblastoma multiforme

- Anaplastic astrocytoma

- Anaplastic oligodendroglioma

- Anaplastic mixed oligoastrocytoma

- Low-grade glioma

- Meningioma

- Ependymoma

- Other primary brain tumor histologies

- Planning to undergo external-beam cranial radiotherapy (partial- or whole-brain

radiotherapy) meeting all of the following criteria:

- Total dose ≥ 4,500 cGy

- Total number of fractions ≥ 25 fractions

- Dose per fraction ≥ 150 cGy

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- Hemoglobin ≥ 10. 0 g/dL (erythropoietin or transfusion allowed for symptomatically

anemic patients with a hemoglobin < 10 g/dL)

- Creatinine ≤ 2 mg/dL

- Total bilirubin ≤ 2 times upper limit of normal (ULN)

- SGOT and SGPT ≤ 3 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Sexually active women of childbearing potential must use a reliable method of birth

control

- It is recommended that patients use non-hormonal contraceptives, in addition to

or in place of hormonal contraceptives, during and for one month following treatment with armodafinil

- Prior malignancies allowed

- No baseline headaches (i. e., headaches occurring in the week before baseline

assessment) of grade 4 severity (defined as severe and disabling headaches, requiring analgesics, and interfering with and preventing function or activities of daily living)

- No concurrent uncontrolled illness that may cause fatigue; interfere with drug

absorption, distribution, metabolism, or excretion; or limit compliance with study requirements including, but not limited to, any of the following:

- Ongoing or active infection

- Chronic renal insufficiency

- Psychiatric illness (psychosis, psychotic disorder, history of suicide attempt,

or actively suicidal)

- Extreme social situations (e. g., transportation issues that would preclude study

compliance)

- Patients with a history of cardiac issues (symptomatic congestive heart failure,

unstable angina pectoris, cardiac arrhythmia) should not use armodafinil as it may cause chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG

- No history of allergic reaction attributed to modafinil or armodafinil

- No anticipated or planned excessive consumption of coffee, tea, and/or

caffeine-containing beverages averaging > 600 mg of caffeine/day (i. e., approximately 6 cups of coffee/day, 12 cups of hot tea/day, or 12 cans of cola/day) PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior fractionated external-beam cranial radiotherapy

- More than 30 days since prior monoamine oxidate inhibitors or investigational drugs

- More than 2 weeks since prior and no concurrent modafinil (Provigil), donepezil

(Aricept), memantine hydrochloride (Namenda), methylphenidate (Ritalin), dextroamphetamine-amphetamine (Adderall), ginkgo biloba, or any other cognitive function-enhancing drugs

- At least 4 weeks since prior and no concurrent interstitial or intracavitary

chemotherapy and/or radiotherapy or stereotactic radiosurgery (i. e., Gamma Knife, Linac, or Cyberknife)

- No concurrent erythropoietin, transfusion, or iron therapy (unless patient is

symptomatically anemic with hemoglobin < 10 g/dL)

- Concurrent chemotherapy allowed

- Concurrent hormonal therapy for other malignancies allowed

- No concurrent non-hormonal therapy (e. g., Herceptin and other targeted agents),

or cytotoxic chemotherapy

- No concurrent clopidogrel bisulfate (Plavix)

Locations and Contacts

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

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 2010
Last updated: April 3, 2013

Page last updated: August 23, 2015

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