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

July 21, 2017 updated by: Claudia M. Witt, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20357
        • Mammazentrum Hamburg am Krankenhaus Jerusalem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Usual care + acupuncture
Other: 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
Other: Usual care
Patients of this group receive usual care only

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being
Time Frame: 3 month
3 month
Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being
Time Frame: 6 month
6 month
Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time Frame: 3 month
3 month
Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time Frame: 6 month
6 month
Pain, quality of sleep, and nausea (single items of the FACT-B)
Time Frame: 3 month
3 month
Pain, quality of sleep, and nausea (single items of the FACT-B)
Time Frame: 6 month
6 month
Functional Assessment of Chronic Illness Therapy-Fatigue
Time Frame: 3 month
3 month
Functional Assessment of Chronic Illness Therapy-Fatigue
Time Frame: 6 month
6 month
FACT/GOG-NTX, polyneuropathy symptoms
Time Frame: 3 month
3 month
FACT/GOG-NTX, polyneuropathy symptoms
Time Frame: 6 month
6 month
Quality of Life (SF-12 Health Survey)
Time Frame: 3 month
3 month
Quality of Life (SF-12 Health Survey)
Time Frame: 6 month
6 month
Survival without relapse
Time Frame: 6 month
6 month
Survival
Time Frame: 6 month
6 month
Adverse effects and Interactions
Time Frame: 3 month
3 month
Adverse effects and Interactions
Time Frame: 6 month
6 month
Satisfaction and patient-reported effectiveness
Time Frame: 3 month
This will only be assessed in the acupuncture arm
3 month
Satisfaction and patient-reported effectiveness
Time Frame: 6 month
This will only be assessed in the acupuncture arm
6 month
Goal Attainment Scale
Time Frame: 3 month
This will only be assessed in the acupuncture arm
3 month
Goal Attainment Scale
Time Frame: 6 month
This will only be assessed in the acupuncture arm
6 month
Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)
Time Frame: 3 month
3 month
Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany
Dorit und Alexander Otto Stiftung, Hamburg, Germany

Investigators

  • Principal Investigator: Martin Carstensen, Prof. MD, Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (ESTIMATE)

November 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACU in breast cancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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