Breast Cancer
Conditions
Keywords
Breast Cancer, Acupuncture, Quality of Life
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.
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.
Interventions
Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care
OTHERUsual care
Patients of this group receive usual care only
Sponsors
Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany
Prof. Otto Beisheim Foundation
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 6 month |
Secondary
| Measure | Time frame |
|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 3 month |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 3 month | — |
| Pain, quality of sleep, and nausea (single items of the FACT-B) | 3 month | — |
| Functional Assessment of Chronic Illness Therapy-Fatigue | 3 month | — |
| FACT/GOG-NTX, polyneuropathy symptoms | 3 month | — |
| Quality of Life (SF-12 Health Survey) | 3 month | — |
| Survival without relapse | 6 month | — |
| Survival | 6 month | — |
| Adverse effects and Interactions | 3 month | — |
| Satisfaction and patient-reported effectiveness | 3 month | This will only be assessed in the acupuncture arm |
| Goal Attainment Scale | 3 month | This will only be assessed in the acupuncture arm |
| Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values) | 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 | 3 month | — |
Countries
Germany
Outcome results
None listed