NCT00209001

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2003

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 13, 2015

Status Verified

July 1, 2015

Enrollment Period

4.4 years

First QC Date

September 13, 2005

Last Update Submit

July 10, 2015

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Sham acupuncture therapy

SHAM COMPARATOR

Sham acupuncture therapy

Procedure: Sham acupuncture therapy

Acupuncture

ACTIVE COMPARATOR

Acupuncture

Procedure: Acupuncture

Observation

NO INTERVENTION

Observation

Interventions

AcupuncturePROCEDURE

Acupuncture using enhanced Ming Men technique for 20 minutes, twice during 1st week, then once during week 2, 3,and 4.

Acupuncture
Sham acupuncture therapyPROCEDURE

Sham procedure will be insertion of 5 needles for 20 minutes provided twice during first week, then once per week thereafter.

Sham acupuncture therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • 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

You may not qualify if:

  • Receiving therapy with traditional allopathic medicines for hot flashes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Peter Johnstone, MD

    Emory University Winship Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 13, 2015

Record last verified: 2015-07

Locations

US(1)