Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture therapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer
Eligibility 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
Sites / Locations
- Emory University Winship Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
No Intervention
Arm Label
Sham acupuncture therapy
Acupuncture
Observation
Arm Description
Sham acupuncture therapy
Acupuncture
Observation
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00209001
Brief Title
Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer
Official Title
Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator Peter Johnstone, MD relocated to another institution
Study Start Date
July 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham acupuncture therapy
Arm Type
Sham Comparator
Arm Description
Sham acupuncture therapy
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
Acupuncture
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Observation
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture using enhanced Ming Men technique for 20 minutes, twice during 1st week, then once during week 2, 3,and 4.
Intervention Type
Procedure
Intervention Name(s)
Sham acupuncture therapy
Intervention Description
Sham procedure will be insertion of 5 needles for 20 minutes provided twice during first week, then once per week thereafter.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Johnstone, MD
Organizational Affiliation
Emory University Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer
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