Status:
TERMINATED
Treating Chronic Insomnia in Breast Cancer Patients
Lead Sponsor:
Accelerated Community Oncology Research Network
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Chronic Insomnia
Eligibility:
FEMALE
21-60 years
Phase:
PHASE4
Brief 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.
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00337272
Start Date
August 1 2006
End Date
January 1 2009
Last Update
August 22 2011
Active Locations (10)
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1
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
2
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States, 91750
3
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
4
Augusta Oncology Associates, PC
Augusta, Georgia, United States, 30901