Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy- A Pragmatic Randomized Trial
18 Years
N/A
Female
Breast Cancer
Trial Information
Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy- A Pragmatic Randomized Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Outcome Time Frame:
6 month
Safety Issue:
No
Principal Investigator
Martin Carstensen, Prof. MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany
Authority:
Germany: Ethics Commission
Study ID:
ACU in breast cancer
NCT ID:
NCT01727362
Start Date:
October 2012
Completion Date:
January 2014
Related Keywords:
- Breast Cancer
- Breast Cancer
- Acupuncture
- Quality of Life
- Breast Neoplasms
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