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Efficacy of auricular snap acupuncture in treating patients with postoperative breast cancer with depressive states: a randomized controlled trial

Registration number：

ITMCTR2024000761

Date of Last Refreshed on：

2024-12-01

Date of Registration：

2024-12-01

Registration Status：

Prospective registration

Public title：

Efficacy of auricular snap acupuncture in treating patients with postoperative breast cancer with depressive states: a randomized controlled trial

English Acronym：

Scientific title：

Efficacy of auricular snap acupuncture in treating patients with postoperative breast cancer with depressive states: a randomized controlled trial

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Xing Liwei

Study leader：

Zhao Rong

Applicant telephone：

+86 180 8271 3494

Study leader's telephone：

+86 138 8865 9309

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1791536722@qq.com

Study leader's E-mail：

kmzhaorong@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Yunnan Provincial Hospital of Traditional Chinese Medicine 120 Guanghua Street Kunming Yunnan Province China

Study leader's address：

Yunnan Provincial Hospital of Traditional Chinese Medicine 120 Guanghua Street Kunming Yunnan Province China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Yunnan Provincial Hospital of Traditional Chinese Medicine 120 Guanghua Street Kunming Yunnan Province China

Approved by ethic committee：

Approved No. of ethic committee：

2024-KY-030-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical ehtics committee of Yunnan Provincial Hospital of TCM

Date of approved by ethic committee：

2024/8/7 0:00:00

Contact Name of the ethic committee：

MaJun

Contact Address of the ethic committee：

Yunnan Provincial Hospital of Traditional Chinese Medicine120 Guanghua Street Kunming Yunnan China

Contact phone of the ethic committee：

+86 63625561

Contact email of the ethic committee：

ynszyyylunli@126.com

Primary sponsor：

Yunnan Provincial Hospital of Traditional Chinese Medicine

Primary sponsor's address：

120 Guanghua Street Wuhua District Kunming City

Secondary sponsor：

Country：

China

Province：

Yunnan

City：

Kunming

Institution
hospital：

Yunnan Provincial Hospital of Traditional Chinese Medicine

Address：

120 Guanghua Street Kunming Yunnan China

Source(s) of funding：

Yunnan Province Department of Education project

Target disease：

Postoperative breast cancer with depressive states

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

Determining the efficacy and safety of ear acupuncture in patients with postoperative depression after breast cancer surgery

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Those who meet the clinical staging diagnosis of breast (stage I II III) and undergo total mastectomy; (2) Age 18-70 years old with expected survival >3 months; (3) Patients with a score of >50 and <60 on the Self-Depression Scale (SDS) and ≥20 and <35 on the Hamilton Depression Scale (HAMD) with scores that fall into the mild to moderate anxiety and depression state; (4) Patients who were conscious cooperated with the treatment and could cooperate in receiving follow-up visits during the study period.

Exclusion criteria：

(1) Terminally critical patients with breast cancer; (2) Patients with the combination of severe cardiac cerebrovascular hepatic renal hematopoietic system or other malignant tumors; (3) Patients with combined abnormal coagulation function chronic hepatitis primary or secondary thrombocytopenic purpura; (4) Previously diagnosed mental illness and history of disorders of consciousness; (5) Patients with a history of suicidal tendencies schizophrenia bipolar disorder or other mental disorders; (6) Patients who have recently suffered other major events (e.g. divorce widowhood etc.) or traumatic events (e.g. natural disasters man-made disasters etc.). Translated with DeepL.com (free version)

Study execute time：

From 2025-01-01

To      2026-01-01

Recruiting time：

From 2025-01-01

To      2026-01-01

Interventions：

58

Group：

Control group

Sample size：

Intervention：

sham Seirin Pyonex Needles on Auricular points treatment

Intervention code：

58

Group：

Treatment group

Sample size：

Intervention：

Seirin Pyonex Needles on Auricular points treatment

Intervention code：

Total sample size ： 116

Countries of recruitment
and research settings：

Country：

China

Province：

Yunnan

City：

Kunming

Institution/hospital：

First Affiliated Hospital of Kunming Medical University

Level of the institution：

Tertiary A hospital

Outcomes：

Outcome：

Hamilton Depression Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Gamma-Aminobutyric Acid (GABA)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-6

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-8

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-10

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-1β

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Dopamine (DA)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-2

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TNF-α

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Norepinephrine (NE)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Quality of Life Scale for Tumor Patients

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Self-Rating Depression Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Serotonin (5-HT)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Blood

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Female

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random Numbers generated by computers

Blinding：

Eligible patients were randomly treated with Seirin Pyonex Needles on Auricular points or sham Seirin Pyonex Needles on Auricular points at a ratio of 1:1. Independent staff help to establish and manage the randomized database. Patients in both groups were unaware of their group assignment. During each session they were treated in a closed unit. Except for acupuncturists all other researchers including statisticians outcome evaluators and data analysts were unaware of the grouping assignment. In addition acupuncturists were not involved in the outcome evaluation or data analysis.

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Resman will be used to manage data (www.medresman.org.cn)

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form(CRF) and EDC

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

Not stated

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