Clinical Study on Auricular Points Sticking Plus Chinese Medication for Hot Flashes in Breast Cancer Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Auricular Points Sticking for the Treatment of Hot Flashes in Breast Cancer Patients, a Randomized, Controlled Trial

Conditions
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Breast Cancer, Hormonal Therapy, Hot Flashes, Acupuncture

Intervention / Treatment
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* Other: Auricular Points Sticking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary breast cancer after surgical treatment, pathologically diagnosed malignant breast epithelial tumors (breast cancer), immunohistochemistry showed pathological type of estrogen receptor (ER) and / or progesterone receptor (PR) positive. Participants should be currently receiving endocrine therapy with oral administration of SERMS(selective estrogen receptor modulators) only. Participants should be suffered from perimenopausal symptoms,which is the sudden onset of facial skin flushing, sweating, began from chest and neck,often lasts a few seconds to several minutes and then subsided after center body temperature drops, the associated symptoms of heart palpitations, anxiety, impatience and even a sense of panic, and even wake up at night. The interval between the two attacks is more than 10 minutes. Hot flashes occurs during endocrine therapy of breast cancer KPS score >60 score >2 and ECOG Hot flashes (greater than or equal to 3 times the number of hot flashes per day) Symptoms persist for more than 2 weeks Exclusion Criteria: Participants who have uncontrolled diabetes, hyperthyroidism and hypertension and in patients with pheochromocytoma Abnormal blood routine, liver and kidney damage (the index is greater than 1.2 times the upper limit of normal value) Pregnant or lactating women, persons with mental disorders Participants with other cancers Participants are participating in other clinical trials Current chemotherapy treatment period has not yet completed Taking corticosteroids or sex hormone treatment.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Therapeutic auricular points treatment<br>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. | Other: Auricular Points Sticking<br>* 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.<br>|
| Sham Comparator: Placebo auricular points treatment<br>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. | Other: Auricular Points Sticking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 weekslog in data and complete statistics;up to 24 weeksrefine the paper and publish articles | 

Secondary Outcome Measures

| Outcome Measure | 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. | an average of 1 year Collect all cases and fill in CRFs;up to 24 weekslog in data and complete statistics;up to 24 weeksrefine 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 weekslog in data and complete statistics;up to 24 weeksrefine the paper and publish articles |