Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Chronic Graft Versus Host Disease

Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.

Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.

Placebo taken 30 minutes before bedtime days 1-28 of treatment period

Placebo

8 mgs daily for days 1-28 of treatment period

Ramelteon

Edward J. Stepanski, Ph.D.

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.

Treating Chronic Insomnia in Breast Cancer Patients

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

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).

The subject reports how many hours of sleep she got.

The subject reports how many times she woke up during the night.

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.

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.

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.

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.

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.

Takeda Pharmaceuticals North America, Inc.

Accelerated Community Oncology Research Network

Systematic Assessment - subjects were assessed for adverse events at each study visit by either the research coordinator, treating physician, or other appropriate sub-investigator (such as a nurse practitioner or physician assistant).

1 (Placebo)

2 (Ramelteon)

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Early study termination due to slow enrollment; Small sample size analyzed; Some IVRS and Patient Care Monitor (PCM) data were lost and could not be retrieved; Some subject non-compliance with study requirements

Vice President of Scientific Affairs

Screening Period

Treatment Period

Withdrawal Period

Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.

Sleep Efficiency

Quantitative Sleep Parameters - Total Sleep Time

Quantitative Sleep Parameters - Number of Awakenings

Complete improvement

Moderate improvement

Slight improvement

Minimal improvement

No improvement

Qualitative Evaluation of Sleep - Global Sleep Impression

Qualitative Evaluation of Sleep - Quality of Sleep

Screening period: 12 patients with 6 treated with Placebo and 6 with Ramelteon. Treatment period: 11 patients with 4 treated with Placebo and 7 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.

Daytime Function - Fatigue

Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.

Spots Global Cancer Trial Database for Treating Chronic Insomnia in Breast Cancer Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial