Treating Chronic Insomnia in Breast Cancer Patients
Information source: Accelerated Community Oncology Research Network
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Insomnia
Intervention: Placebo (Device); Ramelteon (Drug)
Phase: Phase 4
Status: Suspended
Sponsored by: Accelerated Community Oncology Research Network Official(s) and/or principal investigator(s):
Edward J. Stepanski, Ph.D., Study Chair, Affiliation: Accelerated Community Oncology Research Network
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.
Clinical Details
Official title: Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary endpoint of the study will be the patients sleep efficiency.
Secondary outcome: Quantitative sleep parametersQualitative evaluation of sleep Daytime Function
Eligibility
Minimum age: 21 Years.
Maximum age: 60 Years.
Gender(s): Female.
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 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 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
Locations and Contacts
Wilshire Oncology Medical Group, Inc., La Verne, California 91750, United States
Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut 06360, United States
Augusta Oncology Associates, PC, Augusta, Georgia 30901, United States
North Idaho Cancer Center, Coeur d'Alene, Idaho 83814, United States
Hematology Oncology Centers of the Northern Rockies, Billings, Montana 59101, United States
Tri-County Hematology & Oncology Associates, Canton, Ohio 44718, United States
Pottsville Cancer Center, Pottsville, Pennsylvania 17901, United States
The West Clinic, Memphis, Tennessee 38120, United States
Cancer Specialists of Tidewater, Ltd., Chesapeake, Virginia 23320, United States
Additional Information
Starting date: August 2006
Ending date: January 2009
Last updated: June 16, 2008
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