Trial Search Results

Management of Insomnia in Breast Cancer Patients

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 currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Drug: Armodafinil
  • Behavioral: Brief Behavioral Intervention for Insomnia (BBT-I)
  • Drug: Placebo

Phase:

Phase 2/Phase 3

Eligibility


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

Exclusion Criteria:

   - Have ever taken armodafinil or modafinil

   - Have an unstable medical or psychiatric illness (Axis I - current or within the last 5
   years)

   - Have a history of or uncontrolled cardiac disease, hypertension, severe headaches,
   glaucoma, or seizures

   - Have taken a psycho-stimulant medication within the past 28 days

   - Be currently pregnant or nursing

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of chronic, preexisting insomnia, sleep apnea, or RLS
   syndrome

   - Have taken sleep medication daily for the last 28 days continuously

   - Have severe hepatic impairment

   - Be taking anti-seizure medications

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