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

This study has been terminated.
(PI relocated to another institution.)
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00209001
First received: September 13, 2005
Last updated: May 12, 2009
Last verified: May 2009
  Purpose

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 Intervention
Breast Cancer
Procedure: Acupuncture
Procedure: Sham acupuncture therapy
Procedure: Observation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: July 2003
Estimated Study Completion Date: July 2010
Arms Assigned Interventions
Sham Comparator: 2
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: 1
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: 3
observation
Procedure: Observation
Observation without acupuncture.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Peter Johnstone, MD, Winship Cancer Institute
ClinicalTrials.gov Identifier: NCT00209001     History of Changes
Other Study ID Numbers: 0533-2003
Study First Received: September 13, 2005
Last Updated: May 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Breast Cancer

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

ClinicalTrials.gov processed this record on April 22, 2014