TCM Constitution, Pattern Types, and Disease Factors in Primary Lung Cancer.

Recruiting

• Conditions: Syndrome; Medicine, Chinese Traditional; Risk Factors; Body Constitution

• Registration Number: NCT06143436
• Lead Sponsor: China Medical University Hospital

Brief Summary

Recently, TCM has played an important role in adjuvant therapy for lung cancer. TCM treatment is based on pattern identification, and constitution theory is also used as a tool for TCM to predict the disease progression. Although there have been many researchs related to the pattern identification and constitution of lung cancer, in view of the problems and limitations, further research on lung cancer patients in Taiwan is needed.

This study aims to explore the correlation between TCM constitution, pattern identification, and other related factors in patients with primary lung cancer in Taiwan, hoping to reveal the disease characteristics of lung cancer in TCM theory. This study intends to interview subjects through attending physicians in the thoracic ward and outpatient clinic of the CMUH from November 20th, 2023 to May 19th , 2025, and the subjects will be included in this study after the researchers ask the subjects for consent.

This study will collect the demographic data of the subjects (sex, age, BMI, smoking history) and disease-related clinical data (tumor stage, pathological type, gene mutation, tumor markers, other comorbidities), and the investigator will ask about the subjects' signs according to the Constitution in Chinese Medicine Questionnaire (CCMQ) , ask the subjects' symptoms according to the pattern identification table, obtain the data to analyze their distribution by descriptive statistics, and then analyze the correlation between them by analysis of variance and Chi-square test.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Status Verified: 2023-12
• Study Start: 2023-12-20
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-02
• Primary Completion: 2025-05-19
• Study Completion: 2025-05-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Patients diagnosed with primary lung cancer.
• Age greater than 18 years and less than 100 years.
• After explanation, they agree to join this study and voluntarily sign the subject consent form, and can understand the content of the questionnaire.

Exclusion Criteria

• Pregnant women.
• Severe mental illness that affects the response to the questionnaire.
• Has been treated (e.g., surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, etc.).
• Concomitant with other uncured primary malignancies.
• Patients with other serious primary diseases (such as: liver and kidney dysfunction, hematolymphatic system diseases, etc.).
• Severe respiratory diseases that are not lung cancer (e.g. primary emphysema, interstitial fibrosis, etc.) .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TCM pattern types	20-30 minuts	Ask about the subjects' symptoms according to the pattern identification table
TCM body constitution	20-30 minuts	Ask about the subjects' signs according to the Constitution in Chinese Medicine Questionnaire (CCMQ)

Secondary Outcome Measures

Name	Time	Method
demographic data	1 day	sex, age, BMI, smoking history
disease-related clinical data	1 day	tumor stage, pathological type, gene mutation, tumor markers, other comorbidities

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung City, Taiwan