Clinical trial NCT00337272: Treating Chronic Insomnia in Breast Cancer Patients
Official title: Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Insomnia
Keywords: chronic insomnia
Lead sponsor: Accelerated Community Oncology Research Network
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2006-06-15
Enrollment: 16
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Sleep Efficiency
timeFrame: Every morning during the screening, treatment, and withdrawal periods
Secondary outcomes:
measure: Quantitative Sleep Parameters - Total Sleep Time
timeFrame: Every morning during the screening, treatment, and withdrawal periods
measure: Quantitative Sleep Parameters - Number of Awakenings
timeFrame: Every morning during the screening, treatment, and withdrawal periods
measure: Qualitative Evaluation of Sleep - Global Sleep Impression
timeFrame: Once during the withdrawal period
measure: Qualitative Evaluation of Sleep - Quality of Sleep
timeFrame: Every morning during the screening, treatment, and withdrawal periods
measure: Daytime Function - Fatigue
timeFrame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
measure: Daytime Function - Despair
timeFrame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
measure: Daytime Function - Distress
timeFrame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group, Inc.
state: California
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates
state: Connecticut
city: Augusta
country: United States
facility: Augusta Oncology Associates, PC
state: Georgia
city: Coeur d'Alene
country: United States
facility: North Idaho Cancer Center
state: Idaho
city: Billings
country: United States
facility: Hematology Oncology Centers of the Northern Rockies
state: Montana
city: Canton
country: United States
facility: Tri-County Hematology & Oncology Associates
state: Ohio
city: Pottsville
country: United States
facility: Pottsville Cancer Center
state: Pennsylvania
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Chesapeake
country: United States
facility: Cancer Specialists of Tidewater, Ltd.
state: Virginia
Study officials:
affiliation: Accelerated Community Oncology Research Network
name: Edward J. Stepanski, Ph.D.
role: STUDY_CHAIR
References: