NCT01727362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

4.2 years

First QC Date

November 7, 2012

Last Update Submit

July 21, 2017

Conditions

Breast Cancer

Keywords

Breast CancerAcupunctureQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    6 month

Secondary Outcomes (1)

  • Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    3 month

Other Outcomes (22)

  • Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being

    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

    6 month

  • Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    3 month

  • +19 more other outcomes

Study Arms (2)

Usual care + acupuncture

ACTIVE COMPARATOR
Other: Usual care + acupuncture

Usual care

ACTIVE COMPARATOR
Other: Usual care

Interventions

Usual care + acupunctureOTHER

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

Usual care + acupuncture
Usual careOTHER

Patients of this group receive usual care only

Usual care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, 20357, Germany

Location

Related Publications (2)

  • 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.

    PMID: 34814766DERIVED

  • 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.

    PMID: 31520284DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Martin Carstensen, Prof. MD

    Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 16, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 24, 2017

Record last verified: 2017-07

Locations

DE(1)