Overview
Management of Insomnia in Breast Cancer Patients
Status:
Completed
Completed
Trial end date:
2016-07-01
2016-07-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified). Participants will be randomized into 4 groups: - Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day. - Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day. - Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention. - Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Stanford UniversityCollaborator:
National Cancer Institute (NCI)Treatments:
Armodafinil
Modafinil
Criteria
INCLUSION CRITERIA- Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy
and/or diagnosis of metastatic breast are allowed)
- Have at least 6 weeks of treatment remaining
- ≥ 21 years old
- Able to understand written and spoken English
- Able to swallow medication (until amendment omitting armodafinil treatment)
- Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia
Severity Index (ISI)
EXCLUSION CRITERIA
- Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil
treatment)
- Prior treatment with psycho-stimulant medication within the past 28 days (until
amendment omitting armodafinil treatment)
- Prior treatment with antiseizure medications (until amendment omitting armodafinil
treatment)
- Has continuously taken sleep medication daily for the last 28 days (until amendment
omitting armodafinil treatment)
- History (self-reported) of unstable medical or psychiatric illness (within the last 5
years)
- History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or
seizures (until amendment omitting armodafinil treatment)
- Pregnant or nursing
- History of substance abuse or meet criteria for current alcohol abuse or dependence
- History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg
syndrome (RLS)
- Severe hepatic impairment (until amendment omitting armodafinil treatment)