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Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy

Phase 4
21 Years
60 Years
Not Enrolling
Chronic Insomnia

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Trial Information

Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy

Phase IV, randomized, double-blind, placebo-controlled, parallel-group study to assess the
efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Sleep Efficiency

Outcome Description:

Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed. The total sleep time is reported by the subject. Percent sleep efficiency is calulated as 100*(total sleep time divided by total time in bed).

Outcome Time Frame:

Every morning during the screening, treatment, and withdrawal periods

Safety Issue:


Principal Investigator

Edward J. Stepanski, Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Accelerated Community Oncology Research Network


United States: Institutional Review Board

Study ID:




Start Date:

August 2006

Completion Date:

January 2009

Related Keywords:

  • Chronic Insomnia
  • chronic insomnia
  • Breast Neoplasms
  • Sleep Initiation and Maintenance Disorders



North Idaho Cancer Center Coeur d'Alene, Idaho  83814
Wilshire Oncology Medical Group, Inc. Rancho Cucamonga, California  91730
Eastern Connecticut Hematology and Oncology Associates Norwich, Connecticut  06360
Genesis Cancer Center Hot Springs, Arkansas  71913
Hematology Oncology Centers of the Northern Rockies Billings, Montana  59101
The West Clinic Memphis, Tennessee  38120
Augusta Oncology Associates, PC Augusta, Georgia  30901
Cancer Specialists of Tidewater, Ltd. Chesapeake, Virginia  23320
Tri-County Hematology & Oncology Associates Canton, Ohio  44718
Pottsville Cancer Center Pottsville, Pennsylvania  17901