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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Charite University, Berlin, Germany
Sponsor:
Collaborators:
Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany
Dorit und Alexander Otto Stiftung, Hamburg, Germany
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01727362
First received: November 7, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Other: Usual care + acupuncture
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy- A Pragmatic Randomized Trial

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Pain, quality of sleep, and nausea (single items of the FACT-B) [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Pain, quality of sleep, and nausea (single items of the FACT-B) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Functional Assessment of Chronic Illness Therapy-Fatigue [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Functional Assessment of Chronic Illness Therapy-Fatigue [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • FACT/GOG-NTX, polyneuropathy symptoms [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • FACT/GOG-NTX, polyneuropathy symptoms [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Quality of Life (SF-12 Health Survey) [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Quality of Life (SF-12 Health Survey) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Survival without relapse [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Adverse effects and Interactions [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Adverse effects and Interactions [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • Satisfaction and patient-reported effectiveness [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    This will only be assessed in the acupuncture arm

  • Satisfaction and patient-reported effectiveness [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    This will only be assessed in the acupuncture arm

  • Goal Attainment Scale [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    This will only be assessed in the acupuncture arm

  • Goal Attainment Scale [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    This will only be assessed in the acupuncture arm

  • Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values) [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: October 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727362

Contacts
Contact: Margit Cree +49 30 450 529 262 margit.cree@charite.de
Contact: Benno Brinkhaus, Prof. MD +49 30 450 529 079 benno.brinkhaus@charite.de

Locations
Germany
Mammazentrum Hamburg am Krankenhaus Jerusalem Recruiting
Hamburg, Germany, 20357
Sub-Investigator: Claudia Witt, Prof. MD         
Sub-Investigator: Benno Brinkhaus, Prof. MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
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
  More Information

No publications provided

Responsible Party: Claudia M. Witt, Professor, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01727362     History of Changes
Other Study ID Numbers: ACU in breast cancer
Study First Received: November 7, 2012
Last Updated: January 15, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Breast Cancer
Acupuncture
Quality of Life

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014