Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Effect of Ruji formula combined with shuowang moxibustion on postoperative immune function and circulating tumor cells (DNA) in patients with TNBC

Registration number：

ITMCTR2100004774

Date of Last Refreshed on：

2021-04-23

Date of Registration：

2021-04-23

Registration Status：

Prospective registration

Public title：

Effect of Ruji formula combined with shuowang moxibustion on postoperative immune function and circulating tumor cells (DNA) in patients with TNBC

English Acronym：

Scientific title：

Effect of Ruji formula combined with shuowang moxibustion on postoperative immune function and circulating tumor cells (DNA) in patients with TNBC

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100045740 ; ChiMCTR2100004774

Applicant：

Tian Huaqin

Study leader：

Tian Huaqin

Applicant telephone：

+86 13929969262

Study leader's telephone：

+86 13929969262

Applicant Fax：

Study leader's fax：

Applicant E-mail：

13929969262@139.com

Study leader's E-mail：

13929969262@139.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

6 Qinren Road, Chancheng District, Foshan, Guangdong

Study leader's address：

6 Qinren Road, Chancheng District, Foshan, Guangdong

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Foshan hospital of traditional Chinese medicine

Approved by ethic committee：

Approved No. of ethic committee：

批件【2018】032号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical ethics committee of Foshan hospital of traditional Chinese medicine

Date of approved by ethic committee：

2021/2/1 0:00:00

Contact Name of the ethic committee：

Zhang Bin

Contact Address of the ethic committee：

6 Qinren Road, Chancheng District, Foshan, Guangdong

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Foshan hospital of traditional Chinese medicine

Primary sponsor's address：

6 Qinren Road, Chancheng District, Foshan, Guangdong

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Foshan

Institution
hospital：

Foshan hospital of traditional Chinese medicine

Address：

6 Qinren Road, Chancheng District

Source(s) of funding：

Self-raised, Scientific research projects of traditional Chinese medicine management in Guangdong Province in 2019 (20191314)

Target disease：

breast cancer

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

The goal of this research is 1.To explore the effect of standard adjuvant chemotherapy (control group) and standard adjuvant chemotherapy combined with Ruji formula and shuowangzhi traditional Chinese medicine (Chinese medicine group) on the recurrence and survival of patients with TNBC; 2. In the control group and the traditional Chinese medicine group, the NGS based ctDNA technology was used to detect the minimal residual disease after radical operation and adjuvant treatment in early and medium-term TNBC patients, and on this basis, the recurrence risk was predicted; 3. The changes of ctDNA abundance before and after treatment in the control group and the traditional Chinese medicine group were analyzed, as well as the intervention effect and clinical outcome of the two treatment methods on ctDNA positive cases, so as to ultimately contribute to improving the survival rate of patients with early and medium-term TNBC.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Patients who met the diagnostic criteria of triple negative breast cancer; 2. After standardized treatment in accordance with the guidelines and specifications for breast cancer diagnosis and treatment of China Anti Cancer Association (2015 Edition), the patients with triple negative breast cancer in stage 0-III were in a tumor free state; 3. Aged from 18 to 70 years; 4. ECOG score: 0-1; 5. The expected survival time was more than 9 months; 6. Informed consent to participate in this study, signed informed consent, expected good compliance, follow-up.

Exclusion criteria：

1. Patients with other malignant tumors or immune system diseases (such as AIDS, rheumatism, severe infection, etc.); 2. Previously found to be allergic to drugs contained in Ruji formula and shuowang moxibustion ointment; 3. The skin condition is poor, unable to accept the treatment of shuowang moxibustion; 4. Pregnant women 5. Patients with bone marrow, liver, kidney, heart, lung and immune dysfunction; 6. 3 months before the detection of immune function received treatment that may affect immune function; 7. Other clinical trials were conducted at the same time.

Study execute time：

From 2021-04-01

To      2024-10-01

Recruiting time：

From 2021-04-23

To      2022-04-01

Interventions：

20

Group：

Control group

Sample size：

Intervention：

Standard adjuvant therapy after radical resection

Intervention code：

20

Group：

Traditional Chinese medicine group

Sample size：

Intervention：

Standard adjuvant therapy combined with Ruji formula, shuowang moxibustion and traditional Chinese medicine therapy

Intervention code：

Total sample size ： 40

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Institution/hospital：

Foshan Maternal and Child Health Care Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

Guangdong

City：

Institution/hospital：

Foshan Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Guangdong

City：

Institution/hospital：

Foshan First People's Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Relapse-free survival

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Overall survival rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Others

Note：

Sample Name：

Surgical tissue specimens

Tissue：

Fate of sample 

Others

Note：

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)：

The third-party statisticians use SPSS statistical software to generate random scheme by random number table method.

Blinding：

Not stated

IPD sharing：

Yes

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

In October 2024, the network platform will be adopted.

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

Case Record Form，CRF.

Data Managemen Committee：

No

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

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above