Treating Chronic Insomnia in Breast Cancer Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Insomnia
• Intervention / Treatment: Drug: Placebo; Drug: Ramelteon

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Rozerem

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Accelerated Community Oncology Research Network
• Collaborators: Takeda Pharmaceuticals North America, Inc.
• Investigators: Study Chair: Edward J. Stepanski, Ph.D., Accelerated Community Oncology Research Network

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: June 13, 2006
• First Submitted That Met QC Criteria: June 13, 2006
• First Posted (Estimate): June 15, 2006

Study Record Updates

• Last Update Posted (Estimate): August 22, 2011
• Last Update Submitted That Met QC Criteria: August 18, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: chronic insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: ACORN AEJSINS0601