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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Usual care + acupuncture
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care + acupuncture<br> | Other: Usual care + acupuncture<br>* Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care<br>|
| Active Comparator: Usual care<br> | Other: Usual care<br>* Patients of this group receive usual care only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) |  | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Acupuncture, Quality of Life