Overview

Management of Insomnia in Breast Cancer Patients

Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stanford University
Collaborator:
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)