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Phase 2 Completed N=54 Randomized Quadruple-blind Supportive Care

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

brain tumor · Nervous System Tumors · Cognition Disorders · Fatigue
Source: ClinicalTrials.gov NCT01032200 ↗
Enrolled (actual)
54
Serious AEs
34.0%
Results posted
Feb 2017
Primary outcomePrimary: Retention — 85; 75 percentage of participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Retention
85; 75
PRIMARY
Adherence
92.6; 95.7
SECONDARY
Fatigue
32.4; 36.4
SECONDARY
Sleepiness
7.2; 8.3
SECONDARY
HVLT-IR
21.2; 20.0

Eligibility Criteria

Inclusion Criteria

  • 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 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01032200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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