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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00209001
• Other study ID #: 0533-2003
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: July 10, 2015
• Start date: July 2003
• Est. completion date: December 2007

Study information

• Verified date: July 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Acupuncture
Acupuncture using enhanced Ming Men technique for 20 minutes, twice during 1st week, then once during week 2, 3,and 4.
• Sham acupuncture therapy
Sham procedure will be insertion of 5 needles for 20 minutes provided twice during first week, then once per week thereafter.

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define efficacy of acupuncture to points of the enhanced Ming Men technique for relief of hot flashes after hormonal therapy for breast cancer.		weekly evaluation up to 9 weeks	No