Treating Chronic Insomnia in Breast Cancer Patients
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Placebo; Ramelteon
Intervention description: Placebo taken 30 minutes before bedtime days 1-28 of treatment period; 8 mgs daily for days 1-28 of treatment period
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: Female
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: chronic insomnia

Summary:

      This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the
      treatment of insomnia in patients that have completed their first chemotherapy treatment for
      breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients aged 21-60 years old

          -  Have a negative serum or urine pregnancy test for women of child-bearing potential

          -  Have a three-month or longer history of insomnia

          -  Self-report < 6.5 hours of total sleep time, in addition to a sleep efficiency of less
             than 85%, averaged over two weeks of screening

          -  A score of less than 60 on the Zung Self-Rating Depression Scale

          -  Self-report bedtimes that do not vary by more than two hours on five nights per week

          -  Have completed chemotherapy for breast cancer less than two years prior to study drug
             administration

          -  Have completed chemotherapy for breast cancer for at least two months prior to
             screening visit

          -  Patients that are receiving Herceptin are eligible for study enrollment

          -  Have completed radiation therapy for breast cancer for at least two months prior to
             screening visit

          -  ECOG (Eastern Cooperative Oncology Group)score of 0-1

          -  Be able to read, understand, and provide written informed consent before enrolling in
             the study

          -  Must be willing to comply with all study visits and comply with daily phone calls to
             the IVRS throughout the study

          -  Agree to participate for the entire study period (about two months)

        Exclusion Criteria:

          -  Metastatic disease

          -  Pregnant or lactating female

          -  Self-reports typical consumption of more than five alcoholic beverages on a single day
             or greater than 14 alcoholic beverages weekly

          -  Self-reports use of products containing nicotine of greater than 15 cigarettes daily
             or cannot avoid products containing nicotine during sleep periods

          -  Current use of any of the following medications, and cannot discontinue these
             medications for the duration of the study: Hypnotic medication, Anti-convulsants,
             Anxiolytics, Narcotic analgesics, Medications or supplements containing Melatonin,
             Ketaconazole and Fluconazole

          -  Currently taking fluvoxamine, brand name Luvox

          -  Have symptoms consistent with the diagnosis of any other sleep disorder other than
             insomnia (e.g. obstructive sleep apnea, narcolepsy, restless legs syndrome)

          -  Currently on night or rotating shift work

          -  Self-reports habitual napping of greater than one hour accumulated sleep on 4 or more
             days per week

          -  Has a psychiatric illness that interferes with normal sleep-wake function (e.g. major
             depression, post-traumatic stress disorder)

          -  A score of 60 or greater on the Zung Self-Rating Depression Scale

          -  Has current unstable medical disorder, such as symptomatic congestive heart failure,
             uncontrolled cardiac arrhythmia, or other serious medical condition as determined by
             the Investigator