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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03540251
• Other study ID #: LonghuaH
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2019
• Source: Longhua Hospital
• Contact: Sheng Liu, Doctor
• Phone: 18917763005
• Email: lshtcm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Breast Cancer
• Breast Neoplasms
• Hormonal Therapy
• Hot Flashes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Longhua Hosptial	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Longhua Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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 weeks"log in data and complete statistics;"up to 24 weeks"refine the paper and publish articles
Secondary	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