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

Accelerated Community Oncology Research Network10 sites in 1 country16 target enrollmentAugust 2006

ConditionsChronic Insomnia

InterventionsPlacebo Ramelteon

DrugsPlacebo Ramelteon

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Chronic Insomnia
Sponsor: Accelerated Community Oncology Research Network
Enrollment: 16
Locations: 10
Primary Endpoint: Sleep Efficiency
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

January 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Accelerated Community Oncology Research Network

Responsible Party

Sponsor

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

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)

Arms & Interventions

1 (Placebo)

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

Intervention: Placebo

2 (Ramelteon)

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

Intervention: Ramelteon

Outcomes

Primary Outcomes

Sleep Efficiency

Time Frame: Every morning during the screening, treatment, and withdrawal periods

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 Outcomes

Quantitative Sleep Parameters - Total Sleep Time(Every morning during the screening, treatment, and withdrawal periods)
Quantitative Sleep Parameters - Number of Awakenings(Every morning during the screening, treatment, and withdrawal periods)
Qualitative Evaluation of Sleep - Global Sleep Impression(Once during the withdrawal period)
Qualitative Evaluation of Sleep - Quality of Sleep(Every morning during the screening, treatment, and withdrawal periods)
Daytime Function - Fatigue(Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments)
Daytime Function - 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(Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments)