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Acupuncture for Sleep Disruption in Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01162018
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : May 31, 2013
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Stanford University

Brief Summary:
The proposed study will recruit 60 women with breast cancer who finished undergoing treatment who complain of persistent insomnia problems that began with onset of their cancer diagnosis. The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. PSG data will be collected on the subsample of the population. Data will be gathered via pencil-and-paper measures before, during, immediately following, one month following the completion of treatment and six months after the conclusion of treatment. In addition, actigraphy data (objective sleep continuity data) will be acquired prior to and following treatment

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Breast Cancer Procedure: acupuncture Other: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for Sleep Disruption in Cancer Survivors
Study Start Date : February 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture Arm Procedure: acupuncture
The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. There are ten sessions each lasting approximately 20 minutes. All participants will have PSG data collected.

Sham Comparator: Sham Acupuncture Other: placebo



Primary Outcome Measures :
  1. Fatigue reduction [ Time Frame: 1 month and 3 months post final acupuncture treatment ]
  2. Quality of life [ Time Frame: 1 month and 3 months post final acupuncture treatment ]
  3. Insomnia reduction [ Time Frame: 1 month and 3 months post final acupuncture treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Breast cancer

  • Post treatment
  • With insomnia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162018


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: David Spiegel Stanford University

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01162018     History of Changes
Other Study ID Numbers: BRSADJ0020
1P30AT005886-01 ( U.S. NIH Grant/Contract )
SU-04082010-5642 ( Other Identifier: Stanford University )
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders