Treating Chronic Insomnia in Breast Cancer Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Drug: Placebo
* Drug: Ramelteon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1 (Placebo)<br>Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period. | Drug: Placebo<br>* Placebo taken 30 minutes before bedtime days 1-28 of treatment period<br>|
| Active Comparator: 2 (Ramelteon)<br>Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period. | Drug: Ramelteon<br>* 8 mgs daily for days 1-28 of treatment period<br>* Other names: Rozerem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency | 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). | Every morning during the screening, treatment, and withdrawal periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Sleep Parameters - Total Sleep Time | The subject reports how many hours of sleep she got. | Every morning during the screening, treatment, and withdrawal periods | 
| Quantitative Sleep Parameters - Number of Awakenings | The subject reports how many times she woke up during the night. | Every morning during the screening, treatment, and withdrawal periods | 
| Qualitative Evaluation of Sleep - Global Sleep Impression | 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. | Once during the withdrawal period | 
| Qualitative Evaluation of Sleep - Quality of Sleep | 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. | Every morning during the screening, treatment, and withdrawal periods | 
| Daytime Function - Fatigue | 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. | Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments | 
| Daytime Function - Despair | 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. | Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments | 
| Daytime Function - Distress | 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. | Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic insomnia