Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors
|ClinicalTrials.gov Identifier: NCT01032200|
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : February 13, 2017
Last Update Posted : November 17, 2017
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|
|Primary Completion Date :||November 2013|
|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.
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|