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

Primary Purpose

Breast Cancer, Hormonal Therapy, Hot Flashes

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Auricular Points Sticking

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

30 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Longhua HosptialRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Therapeutic auricular points treatment

Placebo auricular points treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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) .

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03540251

First Posted

February 10, 2018

Last Updated

March 3, 2019

Sponsor

Longhua Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03540251

Brief Title

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 4, 2019 (Actual)

Primary Completion Date

October 1, 2019 (Anticipated)

Study Completion Date

December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Longhua Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Hormonal Therapy, Hot Flashes, Acupuncture

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Therapeutic auricular points treatment

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo auricular points treatment

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Auricular Points Sticking

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from Baseline Hot Flash Score at 12 weeks

Description

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) .

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

Secondary Outcome Measure Information:

Title

Change from Baseline GCS and MenQoL at 12 weeks

Description

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

Title

Change from Baseline beta-EP at 12 weeks

Description

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.

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

Other Pre-specified Outcome Measures:

Title

Safety and Tolerability-treatment-related adverse events

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

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

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

postoperative breast cancer patients who are receiving who hormonal therapy

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sheng Liu, Doctor

Phone

18917763005

lshtcm@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheng Liu, Doctor

Organizational Affiliation

Shanghai University of Traditional Chinese Medincine Afflicated Longhua Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Longhua Hosptial

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hu Jingyi, Master

Phone

18901910719

13818879096@139.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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