NCT00081965

Brief Summary

RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 27, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

First QC Date

April 27, 2004

Last Update Submit

December 11, 2012

Conditions

Breast CancerHot Flashes

Keywords

breast cancer in situstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IV breast cancerrecurrent breast cancerstage IIIC breast cancerhot flashes

Outcome Measures

Primary Outcomes (1)

  • Frequency and severity of hot flashes, as measured by a hot flash diary

Interventions

acupuncture therapyPROCEDURE
hot flashes attenuationPROCEDURE
management of therapy complicationsPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer (including in situ disease) * Must be receiving treatment for breast cancer at Memorial Sloan Kettering Cancer Center (MSKCC) or its regional site (Commack) * Has an average of 3 or more hot flashes a day during 1 week of baseline diary recording * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Pre- or postmenopausal * Karnofsky performance status 70-100% * Ambulatory * No skin infection PRIOR CONCURRENT THERAPY: * More than 3 weeks since prior and no concurrent treatment with any of the following during the 6 week evaluation period of the trial: * Surgery * Initiation of a new chemotherapy regimen * Initiation of immunotherapy * Initiation of radiotherapy * Initiation or cessation of hormonal therapy * More than 6 weeks since prior acupuncture treatment (6 months for acupuncture specifically for the treatment of hot flashes) * No concurrent pharmacological treatment for hot flashes unless dose has been stable for 4 weeks * No concurrent selective serotonin reuptake inhibitors (SSRIs) unless dose has been stable for 4 weeks

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Deng G, Vickers A, Yeung S, D'Andrea GM, Xiao H, Heerdt AS, Sugarman S, Troso-Sandoval T, Seidman AD, Hudis CA, Cassileth B. Randomized, controlled trial of acupuncture for the treatment of hot flashes in breast cancer patients. J Clin Oncol. 2007 Dec 10;25(35):5584-90. doi: 10.1200/JCO.2007.12.0774.

    PMID: 18065731RESULT

MeSH Terms

Conditions

Breast NeoplasmsHot FlashesBreast Carcinoma In Situ

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Barrie R. Cassileth, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2004

First Posted

April 28, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

US(1)