Auricular Points Sticking for the Treatment of Hot Flashes in Breast Cancer Patients, a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change from Baseline Hot Flash Score at 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Auricular Points Sticking (Other)
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.
干预措施: Auricular Points Sticking (Other)
结局指标
主要结局
Change from Baseline Hot Flash Score at 12 weeks
时间窗: "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
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) .
次要结局
- Change from Baseline GCS and MenQoL at 12 weeks("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("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)
研究者
Sheng Liu
professor
Longhua Hospital