Breast CancerNCT01727362
Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy
A study of Breast Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Usual care + acupuncture, Usual care
- Keywords
- Breast Cancer, Acupuncture, Quality of Life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care + acupunctureOther
Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care
Usual careOther
Patients of this group receive usual care only
| Study group | Role | What they receive |
|---|---|---|
| Usual care + acupuncture | Active comparator | Not described Receives: Other: Usual care + acupuncture |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Measured: 6 month
Secondary outcomes (1)
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany, Prof. Otto Beisheim Foundation
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Martin Carstensen, Prof. MD, Principal investigator, Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727362
- Sponsor's protocol ID
- ACU in breast cancer
- Status last verified
- Jul 2017
- First submitted
- 7 Nov 2012
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34814766Brinkhaus 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.
PubMed 31520284
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy- A Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT01727362
- Acronym / sponsor ID
- ACU in breast cancer
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Acupuncture, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany, Prof. Otto Beisheim Foundation
- Study start
- Oct 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care + acupuncture | Active comparator | Other: Usual care + acupuncture |
| Usual care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care + acupuncturePatients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care | Other | Usual care + acupuncture |
| Usual carePatients of this group receive usual care only | Other | Usual care |
Primary outcome
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time frame: 6 month
1 secondary outcome
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Derived from this study: PubMed 34814766Stockigt 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.
- Derived from this study: PubMed 31520284Brinkhaus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Carstensen, Prof. MD principal investigator
Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Breast Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01727362, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.