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

NCT ID: NCT01727362

Last Updated: 2017-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-12-31

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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care + acupuncture

Group Type ACTIVE_COMPARATOR

Usual care + acupuncture

Intervention Type OTHER

Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care

Usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Patients of this group receive usual care only

Interventions

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Usual care + acupuncture

Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care

Intervention Type OTHER

Usual care

Patients of this group receive usual care only

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany

UNKNOWN

Sponsor Role collaborator

Prof. Otto Beisheim Foundation

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia M. Witt

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Carstensen, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany

Locations

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Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Stockigt DMB, Kirschbaum B, Carstensen DMM, Witt DMCM, Brinkhaus DMB. Prophylactic Acupuncture Treatment During Chemotherapy in Patients With Breast Cancer: Results of a Qualitative Study Nested in a Randomized Pragmatic Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211058207. doi: 10.1177/15347354211058207.

Reference Type DERIVED
PMID: 34814766 (View on PubMed)

Brinkhaus B, Kirschbaum B, Stockigt B, Binting S, Roll S, Carstensen M, Witt CM. Prophylactic acupuncture treatment during chemotherapy with breast cancer: a randomized pragmatic trial with a retrospective nested qualitative study. Breast Cancer Res Treat. 2019 Dec;178(3):617-628. doi: 10.1007/s10549-019-05431-5. Epub 2019 Sep 13.

Reference Type DERIVED
PMID: 31520284 (View on PubMed)

Other Identifiers

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ACU in breast cancer

Identifier Type: -

Identifier Source: org_study_id

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