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Clinical Trials/NCT01727362
NCT01727362
Completed
Not Applicable

Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy- A Pragmatic Randomized Trial

Charite University, Berlin, Germany1 site in 1 country140 target enrollmentOctober 2012
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ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Charite University, Berlin, Germany
Enrollment
140
Locations
1
Primary Endpoint
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of this trial is to investigate the effectiveness of acupuncture on quality of life in patients with breast cancer receiving chemotherapy compared to routine care.

Detailed Description

At the Mammazentrum Hamburg, Germany, patients with breast cancer receiving chemotherapy have the opportunity to get acupuncture in addition to conventional therapy to maintain quality of life and to reduce the side effects of the chemotherapy such as gastrointestinal disorders. In this randomized trial we aim to investigate the effectiveness of additional acupuncture compared to routine care in patients with breast cancer.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudia M. Witt

Professor, MD

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • •diagnosed breast cancer (invasive, intraductal, hormone-sensitive and not hormone-sensitive, only locoregional metastases)
  • •current chemotherapy at Mammazentrum Hamburg with regimen FEC/DOC or EC/DOC
  • •willingness to receive acupuncture within the next 6 month if randomized in acupuncture group
  • •willingness to refrain from acupuncture within the next 6 month if randomized in control group
  • •informed consent

Exclusion Criteria

  • •distant metastases
  • •blood coagulation disorder and/or current use of anticoagulants
  • •serious acute or chronic mental or physical disorders
  • •clinically relevant cardiac arrhythmia symptoms
  • •insufficient German language ability

Outcomes

Primary Outcomes

Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

Time Frame: 6 month

Secondary Outcomes

  • Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)(3 month)

Study Sites (1)

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