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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
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
September 13, 2005
Last Updated
July 10, 2015
Sponsor
Emory University
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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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