Trial Search Results

Management of Insomnia in Breast Cancer Patients

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Behavioral: BBT-I
  • Behavioral: Control
  • Drug: Armodafinil

Phase:

Phase 2

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

   - ‚Č• 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)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh, PhD, MPH
650-725-7011
Not Recruiting