Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments usual care + acupuncture, usual care
Sponsor Charite University, Berlin, Germany
Collaborator Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany
Start date October 2012
End date December 2016
Trial size 140 participants
Trial identifier NCT01727362, ACU in breast cancer

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
usual care + acupuncture
Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care
(Active Comparator)
usual care
Patients of this group receive usual care only

Primary Outcomes

Measure
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
time frame: 6 month

Secondary Outcomes

Measure
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
time frame: 3 month

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy- A Pragmatic Randomized Trial
Principal investigator Martin Carstensen, Prof. MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.