Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors
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|ClinicalTrials.gov Identifier: NCT01032200|
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : February 13, 2017
Last Update Posted : September 10, 2018
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 or disease||Intervention/treatment||Phase|
|Brain Tumors Nervous System Tumors Cognition Disorders Fatigue||Drug: Armodafinil Other: placebo||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Feasibility Study of Armodafinil for Brain Radiation-Induced Fatigue|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: Arm I - Armodafinil
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.
Placebo Comparator: Arm II - Placebo
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.
- Retention [ Time Frame: 4 weeks post-RT (approximately 3 months post randomization) ]Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.
- Adherence [ Time Frame: 4 weeks post-RT (approximately 3 months post randomization) ]Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)
- Fatigue [ Time Frame: 4 weeks post-RT ]Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. The total Score ranges from 0 to 52, with higher scores indicating less fatigue.
- Sleepiness [ Time Frame: 4 weeks post-RT ]Sleepiness as measured by the Epworth Sleep Scale. It consists of 8 questions that measure daytime sleepiness in which the patient records their likelihood of dozing or sleeping during a number of routine daily activities. ESS scores range from 0 to 24. Higher scores denote greater sleepiness.
- HVLT-IR [ Time Frame: 4 weeks post-RT ]HVLT-IR is the Hopkins Verbal learning test - immediate recall. Participants are given 12 words to remember. They are then asked to recall those words. This is repeated 3 times. Minimum recalled words 0 maximum 36. The HVLT-IR score is the sum of correctly recalled words across the three trials. Higher scores indicate better recall.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032200
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||Edward G. Shaw, MD||Wake Forest University Health Sciences|