Clinical Study on Auricular Points Sticking Plus Chinese Medication for Hot Flashes in Breast Cancer Women
NCT ID: NCT03540251
Last Updated: 2019-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
92 participants
INTERVENTIONAL
2019-01-04
2019-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Therapeutic auricular points treatment
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.
Auricular Points Sticking
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.
Placebo auricular points treatment
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.
Auricular Points Sticking
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.
Interventions
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Auricular Points Sticking
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
55 Years
FEMALE
No
Sponsors
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Longhua Hospital
OTHER
Responsible Party
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Sheng Liu
professor
Principal Investigators
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Sheng Liu, Doctor
Role: STUDY_DIRECTOR
Shanghai University of Traditional Chinese Medincine Afflicated Longhua Hospital
Locations
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Longhua Hosptial
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LonghuaH
Identifier Type: -
Identifier Source: org_study_id
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