Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Usual care + acupuncture; Other: Usual care

• Registration Number: NCT01727362
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-21
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care + acupuncture	Usual care + acupuncture	-
Usual care	Usual care	-

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)	6 month

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)	3 month

Trial Locations

Locations (1)

Mammazentrum Hamburg am Krankenhaus Jerusalem; 🇩🇪 Hamburg, Germany