Treating Chronic Insomnia in Breast Cancer Patients

Chronic Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00337272
• Other study ID #: ACORN AEJSINS0601
• Status: Terminated
• Phase: Phase 4
• First received: June 13, 2006
• Last updated: August 18, 2011
• Start date: August 2006
• Est. completion date: January 2009

Study information

• Verified date: August 2011
• Source: Accelerated Community Oncology Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Placebo
Placebo taken 30 minutes before bedtime days 1-28 of treatment period
• Ramelteon
8 mgs daily for days 1-28 of treatment period

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Accelerated Community Oncology Research Network	Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No