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

Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors
This study is currently recruiting participants.
Verified June 2011 by Wake Forest University

First Received on December 13, 2009.  
Last Updated on June 28, 2012  
History of Changes
Sponsor: Wake Forest University
Collaborator: National Cancer Institute (NCI)
Information provided by: Wake Forest University
ClinicalTrials.gov Identifier: NCT01032200
  Purpose

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.

Condition Intervention Phase
Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Fatigue
Drug: armodafinil
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Feasibility Study of Armodafinil for Brain Radiation-Induced Fatigue

Resource links provided by NLM:

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

  • Feasibility (accrual, retention, adherence, patient availability, and agreement to participate in study) [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Toxicity as measured by the CTEP active version of the CTCAE [ Designated as safety issue: Yes ]
  • Fatigue as measured by the FACIT-F and Brief Fatigue Inventory [ Designated as safety issue: No ]
  • Overall quality of life as measured by the FACT-Br [ Designated as safety issue: No ]
  • Sleepiness as measured by the Epworth Sleep Scale [ Designated as safety issue: No ]
  • Cognitive function as measured by the Wake Forest Cognitive Function Battery [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: August 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Experimental: 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.
Drug: armodafinil

Given orally
Placebo Comparator: 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.
Other: placebo

Given orally

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032200

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office – Wake Forest University Comprehensive     336-713-6771        
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Edward G. Shaw, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:

No publications provided

Responsible Party: Edward G. Shaw, Wake Forest University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01032200    
History of Changes
Other Study ID Numbers: CCCWFU97509, CCCWFU-97509, CEPHALON-CCCWFU-97509
Study First Received: December 13, 2009
Last Updated: June 28, 2012
Health Authority: United States: Federal Gov

Keywords provided by Wake Forest University:

fatigue
cognitive/functional effects
adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult diffuse astrocytoma
adult pilocytic astrocytoma
adult pineal gland astrocytoma
adult subependymal giant cell astrocytoma
adult oligodendroglioma
adult anaplastic ependymoma
adult ependymoma
adult myxopapillary ependymoma
adult subependymoma
adult anaplastic meningioma
adult grade I meningioma
adult grade II meningioma
adult grade III meningioma
adult papillary meningioma
adult brain stem glioma

Additional relevant MeSH terms:

Fatigue
Nervous System Neoplasms
Central Nervous System Neoplasms
Brain Neoplasms
Signs and Symptoms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 21, 2012

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