Treating Chronic Insomnia in Breast Cancer Patients

Accelerated Community Oncology Research Network

Status and phase

Terminated

Phase 4

Conditions

Chronic Insomnia

Treatments

Drug: Placebo

Drug: Ramelteon

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00337272

ACORN AEJSINS0601

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

Female

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

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