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Management of Insomnia in Breast Cancer Patients - NCT01011218-14642(Clinical Trial 400310)



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City:  Rochester
State:  
NY
Zip Code: 14642
Conditions: Insomnia - Fatigue
Purpose: Primary Objective: 1. To provide preliminary data on the effects of armodafinil and Brief Behavioral Therapy for Insomnia (BBT-I) (alone or in combination) on insomnia in breast cancer patients receiving chemotherapy. Secondary Objectives: 1. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on cancer-related fatigue (CRF) in breast cancer patients receiving chemotherapy. 2. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on QOL in breast cancer patients receiving chemotherapy. 3. To provide preliminary data on influence of armodafinil and BBT-I (alone or in combination) on endocrine and inflammatory physiological markers (measured by cortisol and inflammatory cytokines markers)
Study summary:
Criteria: Inclusion Criteria: - be scheduled for planned treatment with chemotherapy for cancer - have at least 6 weeks of chemotherapy treatments remaining - be at least 21 years - be able to understand written and spoken English - be able to swallow medication - exhibit onset or worsening of problems falling or staying asleep Exclusion Criteria: - have ever taken armodafinil or modafinil - have an unstable self-reported medical or psychiatric illness (Axis I - current or within the last 5 years) - have a history of, or uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, seizures - have taken a psycho-stimulant medication within the past 28 days be currently pregnant or nursing (patients are monitored for pregnancy during chemotherapy and pregnant women in the first trimester are not administered chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance to the study). - have a history of substance abuse or meet criteria for current alcohol abuse or dependence - have a self-reported history of chronic pre-existing chronic insomnia (duration ≥6 months), sleep apnea, or RLS syndrome - have severe hepatic impairment (will be known prior to entrance to the study per medical record) - have taken sleep medication daily for the last 28 days - be taking antiseizure medications
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Data Source: ClinicalTrials.gov
Date Processed: December 15, 2010
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