Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy
This study is currently recruiting participants.
Verified November 2012 by Charite University, Berlin, Germany
Sponsor:
Charite University, Berlin, Germany
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: November 12, 2012
Last verified: November 2012
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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
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: | November 12, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Charite University, Berlin, Germany:
|
Breast Cancer Acupuncture Quality of Life |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013