A clinical study of Daoyin Recipe for patients with lung cancer to improve postoperative symptoms of lung cancer

Registration number:

ITMCTR2200005837

Date of Last Refreshed on:

2022-04-09

Date of Registration:

2022-04-09

Registration Status:

Prospective registration

Public title:

A clinical study of Daoyin Recipe for patients with lung cancer to improve postoperative symptoms of lung cancer

English Acronym:

Scientific title:

A clinical study of Daoyin Recipe for patients with lung cancer to improve postoperative symptoms of lung cancer

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2200058484 ; ChiMCTR2200005837

Applicant:

Xiaofeng Yang

Study leader:

Lingshuang Liu

Applicant telephone:

17321334280

Study leader's telephone:

18917763369

Applicant Fax:

Study leader's fax:

Applicant E-mail:

xiaofengy1@126.com

Study leader's E-mail:

liuls107@163.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

Doctor's Office, 10th Floor, Building 11, 725 Wanping Road South, Xuhui District, Shanghai

Study leader's address:

Doctor's Office, 10th Floor, Building 11, 725 Wanping Road South, Xuhui District, Shanghai

Applicant postcode:

200032

Study leader's postcode:

200032

Applicant's institution:

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

2021LCSY125

Approved file of Ethical Committee:

View

Name of the ethic committee:

Institutional Review Board Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Date of approved by ethic committee:

2021/11/25 0:00:00

Contact Name of the ethic committee:

Lei Liu

Contact Address of the ethic committee:

725 Wanping Road South, Xuhui District, Shanghai

Contact phone of the ethic committee:

+86 021-64385700-1318

Contact email of the ethic committee:

Primary sponsor:

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Primary sponsor's address:

725 Wanping Road South, Xuhui District, Shanghai

Secondary sponsor:

Country:

China

Province:

Shanghai

City:

Institution
hospital:

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Address:

725 Wanping Road South, Xuhui District

Source(s) of funding:

Shanghai Municipal Health Commission

Target disease:

lung cancer

Target disease code:

Study type:

Interventional study

Study design:

Cohort study

Study phase:

New Treatment Measure Clinical Study

Objectives of Study:

To observe the clinical efficacy of Daoyin Recipe on improving clinical symptoms, quality of life, cardiopulmonary function and immune function of postoperative lung cancer patients. Then , establishing a Chinese medicine comprehensive rehabilitation which can be clinically popularized and standardized.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

①Stage I-IIIa postoperative patients, primary bronchogenic carcinoma diagnosed by pathology ; ②No postoperative treatment or postoperative adjuvant therapy has been completed for more than 1 month; ③ Any item(GP1, GP3, B1, L2, L4)in FACT-L scale is more than 2 points, or any item score of GF1, GF5, C6 is less than 2 points; ④Age between 18 and 75 years old (including 18 and 75 years old); ⑤ECOG PS is less than 2 points; ⑥No serious heart, liver, kidney and other organ diseases; clear consciousness, no mental system diseases; ⑦The patient has good compliance, can understand the situation of this study and sign the informed consent form.

Exclusion criteria:

①expected survival less than 6 months ②patients with pregnancy or lactation ③patients with severe osteoporosis ④patients with uncontrollable mental history; ⑤patients meet the contraindication criteria of cardiopulmonary exercise test.

Study execute time:

From 2022-01-01

To      2024-12-31

Recruiting time:

From 2022-04-01

To      2024-03-01

Interventions:

71

Group:

exposed group

Sample size:

Intervention:

Dao yin for lung cancer combined with Yifei Jianpi Recipe

Intervention code:

71

Group:

non-exposed group

Sample size:

Intervention:

Yifei Jianpi Recipe

Intervention code:

Total sample size : 142

Countries of recruitment
and research settings:

Country:

China

Province:

Shanghai

City:

Institution/hospital:

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

Outcomes:

Outcome:

immune function

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

CPET

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

FACT-L

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

symptoms lists questionnaire of traditional Chinese medicine

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

side effects

Type:

Adverse events

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

blood

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

18
Min age years
75
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

The study is a cohort observational study. According to the results of the questionnaire survey, the patients who met the research conditions will enter into different treatment groups according to the patients' willingness.

Blinding:

IPD sharing:

No

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

Do not share raw data

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

All of the original data records are preserved by the head of this study, and the electronic version records are managed by excel and spss.

Data Managemen Committee:

Not yet

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above