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)

Stanford Investigator(s):


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


Phase 2



   - 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)


   - Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil

   - 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

   - 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

   - 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


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