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| Name | Class |
|---|---|
| Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany | UNKNOWN |
| Prof. Otto Beisheim Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care + acupuncture | Active Comparator |
| |
| Usual care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care + acupuncture | Other | Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 3 month |
| 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 | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Carstensen, Prof. MD | Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mammazentrum Hamburg am Krankenhaus Jerusalem | Hamburg | 20357 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34814766 | Derived | 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. | |
| 31520284 | Derived |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Usual care | Other | Patients of this group receive usual care only |
|
| 6 month |
| Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 3 month |
| Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 6 month |
| Pain, quality of sleep, and nausea (single items of the FACT-B) | 3 month |
| Pain, quality of sleep, and nausea (single items of the FACT-B) | 6 month |
| Functional Assessment of Chronic Illness Therapy-Fatigue | 3 month |
| Functional Assessment of Chronic Illness Therapy-Fatigue | 6 month |
| FACT/GOG-NTX, polyneuropathy symptoms | 3 month |
| FACT/GOG-NTX, polyneuropathy symptoms | 6 month |
| Quality of Life (SF-12 Health Survey) | 3 month |
| Quality of Life (SF-12 Health Survey) | 6 month |
| Survival without relapse | 6 month |
| Survival | 6 month |
| Adverse effects and Interactions | 3 month |
| Adverse effects and Interactions | 6 month |
| Satisfaction and patient-reported effectiveness | This will only be assessed in the acupuncture arm | 3 month |
| Satisfaction and patient-reported effectiveness | This will only be assessed in the acupuncture arm | 6 month |
| Goal Attainment Scale | This will only be assessed in the acupuncture arm | 3 month |
| Goal Attainment Scale | This will only be assessed in the acupuncture arm | 6 month |
| Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values) | 3 month |
| Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values) | 6 month |
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |