Treating Chronic Insomnia in Breast Cancer Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Insomnia	Drug: Placebo Drug: Ramelteon	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ramelteon

U.S. FDA Resources

Further study details as provided by Accelerated Community Oncology Research Network:

Primary Outcome Measures:

Sleep Efficiency [ Time Frame: Every morning during the screening, treatment, and withdrawal periods ] [ Designated as safety issue: No ]
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:

Quantitative Sleep Parameters - Total Sleep Time [ Time Frame: Every morning during the screening, treatment, and withdrawal periods ] [ Designated as safety issue: No ]
The subject reports how many hours of sleep she got.
Quantitative Sleep Parameters - Number of Awakenings [ Time Frame: Every morning during the screening, treatment, and withdrawal periods ] [ Designated as safety issue: No ]
The subject reports how many times she woke up during the night.
Qualitative Evaluation of Sleep - Global Sleep Impression [ Time Frame: Once during the withdrawal period ] [ Designated as safety issue: No ]
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 [ Time Frame: Every morning during the screening, treatment, and withdrawal periods ] [ Designated as safety issue: No ]
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 [ Time Frame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments ] [ Designated as safety issue: No ]
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 [ Time Frame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments ] [ Designated as safety issue: No ]
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 [ Time Frame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments ] [ Designated as safety issue: No ]
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.

Enrollment:	16
Study Start Date:	August 2006
Study Completion Date:	January 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 (Placebo) Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.	Drug: Placebo Placebo taken 30 minutes before bedtime days 1-28 of treatment period
Active Comparator: 2 (Ramelteon) Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.	Drug: Ramelteon 8 mgs daily for days 1-28 of treatment period Other Name: Rozerem

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

Ages Eligible for Study:	21 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337272

Locations

United States, Arkansas
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
Wilshire Oncology Medical Group, Inc.
La Verne, California, United States, 91750
United States, Connecticut
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Georgia
Augusta Oncology Associates, PC
Augusta, Georgia, United States, 30901
United States, Idaho
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States, 83814
United States, Montana
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, United States, 59101
United States, Ohio
Tri-County Hematology & Oncology Associates
Canton, Ohio, United States, 44718
United States, Pennsylvania
Pottsville Cancer Center
Pottsville, Pennsylvania, United States, 17901
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Virginia
Cancer Specialists of Tidewater, Ltd.
Chesapeake, Virginia, United States, 23320

Sponsors and Collaborators

Accelerated Community Oncology Research Network

Takeda Pharmaceuticals North America, Inc.

Investigators

Study Chair:

Edward J. Stepanski, Ph.D.

Accelerated Community Oncology Research Network

More Information

No publications provided

Responsible Party:	Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:	NCT00337272 History of Changes
Other Study ID Numbers:	ACORN AEJSINS0601
Study First Received:	June 13, 2006
Results First Received:	June 2, 2009
Last Updated:	August 18, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Accelerated Community Oncology Research Network:

chronic insomnia

Additional relevant MeSH terms:

Breast Neoplasms
Sleep Initiation and Maintenance Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013