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Management of Insomnia in Breast Cancer Patients
Not Recruiting
Trial ID: NCT01011218
Purpose
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.
Official Title
Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study
Stanford Investigator(s)
David Spiegel
Jack, Lulu and Sam Willson Professor of Medicine
Frank E. Stockdale
Maureen Lyles D'Ambrogio Professor in the School of Medicine, Emeritus
Eligibility
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)
Intervention(s):
drug: Armodafinil
behavioral: BBT-I
behavioral: Control
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Oxana Palesh, PhD, MPH
650-725-7011