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Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer

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ClinicalTrials.gov Identifier: NCT00209001
Recruitment Status : Terminated (Principal investigator Peter Johnstone, MD relocated to another institution)
First Posted : September 21, 2005
Last Update Posted : July 13, 2015
Sponsor:
Information provided by (Responsible Party):
Keerthi Gogineni, Emory University

Brief Summary:
The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Acupuncture Procedure: Sham acupuncture therapy

Detailed Description:

The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.

Hormonal therapy is one of the most common treatments for breast cancer in women. Unfortunately, many women on hormonal therapy suffer from hot flashes (the sudden sensation of heat throughout the face, neck and chest, with or without shivering and sweating). Many medicines have been used to treat hot flashes, but no single medication has been found to work reliably.

Acupuncture has been shown to be effective for many conditions in Western medicine specifically for dry mouth in people who have received radiation to their head and neck, as well as for hot flashes in women during menopause (the "change of life"). In this study, we are investigating whether acupuncture is effective for women suffering hot flashes that result from their treatment of breast cancer.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer
Study Start Date : July 2003
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Sham acupuncture therapy
Sham acupuncture therapy
Procedure: Sham acupuncture therapy
Sham procedure will be insertion of 5 needles for 20 minutes provided twice during first week, then once per week thereafter.
Active Comparator: Acupuncture
Acupuncture
Procedure: Acupuncture
Acupuncture using enhanced Ming Men technique for 20 minutes, twice during 1st week, then once during week 2, 3,and 4.
No Intervention: Observation
Observation



Primary Outcome Measures :
  1. Define efficacy of acupuncture to points of the enhanced Ming Men technique for relief of hot flashes after hormonal therapy for breast cancer. [ Time Frame: weekly evaluation up to 9 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • 18 years of age or older
  • History of breast cancer who have received hormonal therapy
  • Personal history of hot flashes
  • Patients will be accepted if receiving therapy with traditional allopathic medicines if their hot flashes have persisted after two months

Exclusion Criteria:

  • Receiving therapy with traditional allopathic medicines for hot flashes

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): NCT00209001


Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Peter Johnstone, MD Emory University Winship Cancer Institute

Responsible Party: Keerthi Gogineni, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209001     History of Changes
Other Study ID Numbers: 0533-2003
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 13, 2015
Last Verified: July 2015

Keywords provided by Keerthi Gogineni, Emory University:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms