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Object:The aim of this study was to investigate the effectiveness of sticking and massaging auricular points for the management of hot flashes in postoperative breast cancer patients.
Patients and Methods A randomized controlled trial is conducted by comparing effectiveness of sticking and massaging auricular points relieving hot flashes in women with breast cancer versus placebo auricular points. A total of 92 women(still recuiting) with breast cancer, who were under hormonal therapy were randomly assigned and the allocation ratio was 1:1. Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets.In addition, both group received 8 treatment sessions of sticking and pressing predefined auricular points or placebo auricular points treatments.
The primary outcome was hot flash score(HFS)at the end of treatment (week 12), calculated as the frequency multiplied by the average severity of hot flashes.The secondary outcomes were climacteric symptoms and quality of life, measured by the Greene Climacteric Scale(GCS)and Menopause Quality of Life scales(MenQoL)as well as serum estradiol(E2), follicle-stimulating hormone(FSH) and beta-endorphin(β-EP).Expectation and satisfaction of treatment effect and safety were also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic auricular points treatment | Active Comparator | Therapeutic auricular points treatment including auricular points:CO18、TF2、TF4、AT4、CO15（with complaint of sweating）or CO12(with symptom of heart palpitation)in accordance with the position of auricular points Location map of national standard(GBVT13734-2008) Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets. In addition, both group received 8 treatment sessions of sticking and pressing predefined auricular points. |
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| Placebo auricular points treatment | Sham Comparator | Placebo auricular points treatment including auricular points AH9、AH11、TG3、AT2、LO4 in accordance with the position of auricular points Location map of national standard(GBVT13734-2008) Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets.In addition, both group received 8 treatment sessions of sticking and pressing placebo auricular points treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular Points Sticking | Other | Auricular Points Sticking is a kind of acupunture based on Meridians Theory of traditional Chinese Medicine.Sticking and pressing predefined therapeutic auricular points can relieve the frequency and severity of hot flashes and other climacteric symptoms. Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets.In addition, both group received 8 treatment sessions of sticking and pressing predefined auricular points or placebo auricular points treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Hot Flash Score at 12 weeks | Each week's average HFS of both treatment and placebo group was recorded and all the findings were statistically treated by General Estimation Equation(GEE) . | "an average of 1 year" Collect all cases and fill in CRFs;"up to 24 weeks"log in data and complete statistics;"up to 24 weeks"refine the paper and publish articles |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline GCS and MenQoL at 12 weeks | The GCS, also known as Greene Climacteric Scale and MenQoL Score(Menopause-specific Quality of Life Scale) before and after therapy were the secondary outcome measures, the data were statistically analyzed with ne sample t test if conforming to normal distribution, or otherwise, rank tests and Chi-square test should be utilized to analysis the data. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability-treatment-related adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | "an average of 1 year" Collect all cases and fill in CRFs;"up to 24 weeks"log in data and complete statistics;"up to 24 weeks"refine the paper and publish articles |
Inclusion Criteria:
Exclusion Criteria:
postoperative breast cancer patients who are receiving who hormonal therapy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Liu, Doctor | Contact | 18917763005 | lshtcm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Sheng Liu, Doctor | Shanghai University of Traditional Chinese Medincine Afflicated Longhua Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longhua Hosptial | Recruiting | Shanghai | Shanghai Municipality | 021 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| "an average of 1 year" Collect all cases and fill in CRFs;"up to 24 weeks"log in data and complete statistics;"up to 24 weeks"refine the paper and publish articles |
| Change from Baseline beta-EP at 12 weeks | The serum beta-EP before and after therapy was another secondary outcome measure, the laboatatory outcomes were also statistically analyzed with one sample t test. | "an average of 1 year" Collect all cases and fill in CRFs;"up to 24 weeks"log in data and complete statistics;"up to 24 weeks"refine the paper and publish articles |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |