Trial Search Results
Management of Insomnia in Breast Cancer Patients
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.
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)
Stanford is currently not accepting patients for this trial.
Collaborator: National Cancer Institute (NCI)
- Drug: Armodafinil
- Behavioral: Brief Behavioral Intervention for Insomnia (BBT-I)
- Drug: Placebo
Phase 2/Phase 3
- Be scheduled for planned cancer treatment with chemotherapy or biologics, such as
Herceptin (prior chemotherapy and diagnosis of metastatic breast are allowed)
- Have at least 6 weeks of treatment remaining
- Be at least 21 years old
- Be able to swallow medication
- Exhibit onset or worsening of problems falling or staying asleep
- Have ever taken armodafinil or modafinil
- Have an unstable medical or psychiatric illness (Axis I - current or within the last 5
- Have a history of or uncontrolled cardiac disease, hypertension, severe headaches,
glaucoma, or seizures
- Have taken a psycho-stimulant medication within the past 28 days
- Be currently pregnant or nursing
- Have a history of substance abuse or meet criteria for current alcohol abuse or
- Have a self-reported history of chronic, preexisting insomnia, sleep apnea, or RLS
- Have taken sleep medication daily for the last 28 days continuously
- Have severe hepatic impairment
- Be taking anti-seizure medications
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study