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

• ClinicalTrials.gov Identifier: NCT03540251
• Recruitment Status: Unknown
• First Posted: May 30, 2018
• Last Update Posted: March 5, 2019
• Sponsor: Longhua Hospital
• Information provided by (Responsible Party): Sheng Liu, Longhua Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Hormonal Therapy; Hot Flashes; Acupuncture	Other: Auricular Points Sticking	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Auricular Points Sticking for the Treatment of Hot Flashes in Breast Cancer Patients, a Randomized, Controlled Trial
• Actual Study Start Date: January 4, 2019
• Estimated Primary Completion Date: October 1, 2019
• Estimated Study Completion Date: December 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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.
Sham Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline Hot Flash Score at 12 weeks [ Time Frame: "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) .

Secondary Outcome Measures :

1. Change from Baseline GCS and MenQoL at 12 weeks [ Time Frame: "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 ]
   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.
2. Change from Baseline beta-EP at 12 weeks [ Time Frame: "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 ]
   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.

Other Outcome Measures:

1. Safety and Tolerability-treatment-related adverse events [ Time Frame: "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 ]
   Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: postoperative breast cancer patients who are receiving who hormonal therapy
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Sheng Liu, Doctor; 18917763005; lshtcm@163.com

Locations

China, Shanghai

Longhua Hosptial; Recruiting

Shanghai, Shanghai, China, 021

Contact: Hu Jingyi, Master 18901910719 13818879096@139.com

Sponsors and Collaborators

Longhua Hospital

Investigators

• Study Director: Sheng Liu, Doctor; Shanghai University of Traditional Chinese Medincine Afflicated Longhua Hospital

More Information

• Responsible Party: Sheng Liu, professor, Longhua Hospital
• ClinicalTrials.gov Identifier: NCT03540251
• Other Study ID Numbers: LonghuaH
• First Posted: May 30, 2018
• Last Update Posted: March 5, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Hot Flashes; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases