Treating Chronic Insomnia in Breast Cancer Patients
- Registration Number
- NCT00337272
- Lead Sponsor
- Accelerated Community Oncology Research Network
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 16
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 (Placebo) Placebo Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period. 2 (Ramelteon) Ramelteon Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
- Primary Outcome Measures
Name Time Method Sleep Efficiency Every morning during the screening, treatment, and withdrawal periods 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).
- Secondary Outcome Measures
Name Time Method Quantitative Sleep Parameters - Total Sleep Time Every morning during the screening, treatment, and withdrawal periods The subject reports how many hours of sleep she got.
Quantitative Sleep Parameters - Number of Awakenings Every morning during the screening, treatment, and withdrawal periods The subject reports how many times she woke up during the night.
Qualitative Evaluation of Sleep - Global Sleep Impression Once during the withdrawal period The Patient Global Impression is a 7-point scale which asks "How much has your sleep improved?" with the following anchors: no improvement, minimal improvement, slight improvement, moderate improvement, very good improvement, near complete improvement, and complete improvement.
Qualitative Evaluation of Sleep - Quality of Sleep Every morning during the screening, treatment, and withdrawal periods The subject rates the quality of her sleep on a scale of 0 through 10, where 0 is a very bad night of sleep and 10 is a very good night of sleep.
Daytime Function - Fatigue Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments The subject rates her fatigue on a scale of 0 through 10, where 0 is not a problem and 10 is as bad as possible.
Daytime Function - Despair Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments The subject rates 7 questions related to despair on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 7 questions are combined and normalized, and used to describe despair.
Daytime Function - Distress Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments The subject rates 4 questions related to distress on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 4 questions are combined and normalized, and used to describe distress.
Trial Locations
- Locations (10)
Augusta Oncology Associates, PC
🇺🇸Augusta, Georgia, United States
Hematology Oncology Centers of the Northern Rockies
🇺🇸Billings, Montana, United States
Eastern Connecticut Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
North Idaho Cancer Center
🇺🇸Coeur d'Alene, Idaho, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸La Verne, California, United States
Tri-County Hematology & Oncology Associates
🇺🇸Canton, Ohio, United States
Pottsville Cancer Center
🇺🇸Pottsville, Pennsylvania, United States
Cancer Specialists of Tidewater, Ltd.
🇺🇸Chesapeake, Virginia, United States