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Acupuncture for Sleep Disruption in Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01162018
First received: July 2, 2010
Last updated: May 23, 2012
Last verified: May 2012
History of Changes

July 2, 2010
May 23, 2012
February 2011
August 2012   (final data collection date for primary outcome measure)
  • Fatigue reduction [ Time Frame: 1 month and 3 months post final acupuncture treatment ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 1 month and 3 months post final acupuncture treatment ] [ Designated as safety issue: No ]
  • Insomnia reduction [ Time Frame: 1 month and 3 months post final acupuncture treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01162018 on ClinicalTrials.gov Archive Site
Not Provided
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Acupuncture for Sleep Disruption in Cancer Survivors
Acupuncture for Sleep Disruption in Cancer Survivors

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Initiation and Maintenance Disorders
  • Breast Cancer
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
56
September 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:- Breast cancer

  • Post treatment
  • With insomnia
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01162018
BRSADJ0020, 1P30AT005886-01, SU-04082010-5642
Yes
Stanford University
Stanford University
  • National Institutes of Health (NIH)
  • National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: David Spiegel Stanford University
Stanford University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP