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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
Genesis Cancer Center
Hot Springs, Arkansas, United States
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
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).
Time frame: Every morning during the screening, treatment, and withdrawal periods
Quantitative Sleep Parameters - Total Sleep Time
The subject reports how many hours of sleep she got.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Augusta Oncology Associates, PC
Augusta, Georgia, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, United States
Tri-County Hematology & Oncology Associates
Canton, Ohio, United States
Pottsville Cancer Center
Pottsville, Pennsylvania, United States
The West Clinic
Memphis, Tennessee, United States
Cancer Specialists of Tidewater, Ltd.
Chesapeake, Virginia, United States
Time frame: 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.
Time frame: 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.
Time frame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments