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

NCT01032200 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB00012856U10CA081851REBACCCWFU97509
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumors; Nervous System Tumors; Cognition Disorders; Fatigue

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Retention

  Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.

  4 weeks post-RT (approximately 3 months post randomization)

• Adherence

  Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)

  4 weeks post-RT (approximately 3 months post randomization)

Secondary Outcomes (3)

• Fatigue

  4 weeks post-RT

• Sleepiness

  4 weeks post-RT

• HVLT-IR

  4 weeks post-RT

Study Arms (2)

Arm I - Armodafinil

EXPERIMENTAL

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

Arm II - Placebo

PLACEBO COMPARATOR

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

Interventions

Armodafinil DRUG

Given orally

Arm I - Armodafinil

placebo OTHER

Given orally

Arm II - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Nervous System Neoplasms; Cognition Disorders; Fatigue; Glioblastoma; Gliosarcoma; Astrocytoma; Oligodendroglioma; Glioma; Ependymoma; Glioma, Subependymal; Meningioma

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Doug Case
• Organization: Wake Forest NCORP Research Base

dcase@wakehealth.edu

(336) 716-1048

Study Officials

• Edward G. Shaw, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2009
• First Posted: December 15, 2009
• Study Start: August 1, 2010
• Primary Completion: January 8, 2013
• Study Completion: January 8, 2013
• Last Updated: September 28, 2021
• Results First Posted: February 13, 2017

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)