Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Primary Objective: 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. Secondary Objectives: 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 not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • behavioral : Brief Behavioral Intervention for Insomnia
  • drug : Armodafinil
  • drug : Placebo

Phase: Phase 2/Phase 3

Eligibility

Ages Eligible For Study:

21 Years - N/A

Inclusion Criteria

- 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

External Links

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Contact information

Primary Contact:

Oxana Palesh, PhD, MPH 650-725-7011

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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