Treating Chronic Insomnia in Breast Cancer Patients

NCT00337272 | Terminated Phase 4 Results

• 1 other identifier: ACORN AEJSINS0601
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 10

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.

Conditions

Chronic Insomnia

Keywords

chronic insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

1 (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo

2 (Ramelteon)

ACTIVE COMPARATOR

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

Drug: Ramelteon

Interventions

Placebo DRUG

Placebo taken 30 minutes before bedtime days 1-28 of treatment period

1 (Placebo)

Ramelteon DRUG

8 mgs daily for days 1-28 of treatment period

Also known as: Rozerem

2 (Ramelteon)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Accelerated Community Oncology Research Network: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (10)

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Wilshire Oncology Medical Group, Inc.

La Verne, California, 91750, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Augusta Oncology Associates, PC

Augusta, Georgia, 30901, United States

Location

North Idaho Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

Hematology Oncology Centers of the Northern Rockies

Billings, Montana, 59101, United States

Location

Tri-County Hematology & Oncology Associates

Canton, Ohio, 44718, United States

Location

Pottsville Cancer Center

Pottsville, Pennsylvania, 17901, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Cancer Specialists of Tidewater, Ltd.

Chesapeake, Virginia, 23320, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

Early study termination due to slow enrollment; Small sample size analyzed; Some IVRS and Patient Care Monitor (PCM) data were lost and could not be retrieved; Some subject non-compliance with study requirements

Results Point of Contact

• Title: Vice President of Scientific Affairs
• Organization: Accelerated Community Oncology Research Network, Inc.

mwalker@acorncro.com

Study Officials

• Edward J. Stepanski, Ph.D.

  Accelerated Community Oncology Research Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 15, 2006
• Study Start: August 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: January 1, 2009
• Last Updated: August 22, 2011
• Results First Posted: July 21, 2009

Record last verified: 2011-08

Locations

US (10)