Treating Chronic Insomnia in Breast Cancer Patients

This study has been terminated.

( Lack of enrollment. )

Study NCT00337272 Information provided by Accelerated Community Oncology Research Network

First Received on June 13, 2006. Last Updated on August 18, 2011 History of Changes

Results First Received: June 2, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Chronic Insomnia
Interventions:	Drug: Placebo Drug: Ramelteon

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
10 community oncology research sites across the United States within Accelerated Community Oncology Research Network (ACORN) participated in this study. Enrollment started in August 2006 and closed in August 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After consent, subjects underwent a 2 week screening period to see if they met the criteria for insomnia and to assess compliance with daily Interactive Voice Recognition System (IVRS) calls.

Reporting Groups

	Description
1 (Placebo)	Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
2 (Ramelteon)	Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.

Participant Flow for 3 periods

Period 1: Screening Period (Pre-randomization)

	1 (Placebo)	2 (Ramelteon)
STARTED	22 ^[1]	0
COMPLETED	16 ^[2]	0
NOT COMPLETED	6	0
Withdrawal by Subject	2	0
Non-compliance	1	0
Screen failure	3	0

[1]	22 subjects were consented. All subjects received placebo during the 2 week screening period.
[2]	16 subjects completed the screening period and were eligible for randomization.

Period 2: Treatment Period

	1 (Placebo)	2 (Ramelteon)
STARTED	7 ^[1]	9 ^[1]
Randomization	7	9
COMPLETED	6	7
NOT COMPLETED	1	2
Non-compliance	1	1
Withdrawal by Subject	0	1

[1]	16 subjects were randomized to either placebo or ramelteon before starting treatment period.

Period 3: Withdrawal Period

	1 (Placebo)	2 (Ramelteon)
STARTED	6 ^[1]	7 ^[1]
COMPLETED	6	6
NOT COMPLETED	0	1
Non-compliance	0	1

[1]	Subjects in both groups received placebo for one week.

Baseline Characteristics

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Reporting Groups

	Description
1 (Placebo)	Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
2 (Ramelteon)	Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.

Baseline Measures

	1 (Placebo)	2 (Ramelteon)	Total
Number of Participants [units: participants]	7	9	16
Age [units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	7	9	16
>=65 years	0	0	0
Age [units: Years] Mean ± Standard Deviation	51.69 ± 5.98	49.11 ± 6.78	50.24 ± 6.37
Gender [units: Participants]
Female	7	9	16
Male	0	0	0
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	2	2
White	7	7	14
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment [units: Participants]
United States	7	9	16

Outcome Measures

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1. Primary:

Sleep Efficiency [ Time Frame: Every morning during the screening, treatment, and withdrawal periods ]

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2. Secondary:

Quantitative Sleep Parameters - Total Sleep Time [ Time Frame: Every morning during the screening, treatment, and withdrawal periods ]

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3. Secondary:

Quantitative Sleep Parameters - Number of Awakenings [ Time Frame: Every morning during the screening, treatment, and withdrawal periods ]

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4. Secondary:

Qualitative Evaluation of Sleep - Global Sleep Impression [ Time Frame: Once during the withdrawal period ]

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5. Secondary:

Qualitative Evaluation of Sleep - Quality of Sleep [ Time Frame: Every morning during the screening, treatment, and withdrawal periods ]

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6. Secondary:

Daytime Function - Fatigue [ Time Frame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments ]

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7. Secondary:

Daytime Function - Despair [ Time Frame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments ]

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8. Secondary:

Daytime Function - Distress [ Time Frame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: PI must provide Sponsor an advance copy of any proposed publication whether in journals or in conferences or other public forum at least 60 days prior to any submission for publication or public presentation so that Sponsor may determine whether it contains any Confidential Information of Sponsor, and/or any discovery or invention is made.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Vice President of Scientific Affairs
Organization: Accelerated Community Oncology Research Network, Inc.
e-mail: mwalker@acorncro.com

No publications provided

Responsible Party:	Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:	NCT00337272 History of Changes
Other Study ID Numbers:	ACORN AEJSINS0601
Study First Received:	June 13, 2006
Results First Received:	June 2, 2009
Last Updated:	August 18, 2011
Health Authority:	United States: Institutional Review Board