Clinical trial NCT03540251: Clinical Study on Auricular Points Sticking Plus Chinese Medication for Hot Flashes in Breast Cancer Women
Official title: Auricular Points Sticking for the Treatment of Hot Flashes in Breast Cancer Patients, a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Hormonal Therapy
Hot Flashes
Acupuncture
Lead sponsor: Longhua Hospital
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 92
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Hot Flash Score at 12 weeks
timeFrame: "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
Secondary outcomes:
measure: Change from Baseline GCS and MenQoL at 12 weeks
timeFrame: "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: Change from Baseline beta-EP at 12 weeks
timeFrame: "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
Other outcomes:
measure: Safety and Tolerability-treatment-related adverse events
timeFrame: "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
Locations:
city: Shanghai
country: China
facility: Longhua Hosptial
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medincine Afflicated Longhua Hospital
name: Sheng Liu, Doctor
role: STUDY_DIRECTOR
References: