Acupuncture for Sleep Disruption in Cancer Survivors

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01162018
First received: July 2, 2010
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention
Sleep Initiation and Maintenance Disorders
Breast Cancer
Procedure: acupuncture
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture for Sleep Disruption in Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 56
Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Breast cancer

  • Post treatment
  • With insomnia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162018

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: David Spiegel Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01162018     History of Changes
Other Study ID Numbers: BRSADJ0020, 1P30AT005886-01, SU-04082010-5642
Study First Received: July 2, 2010
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014