RecruitingNCT07096180

Clinical Observational Studies:Integrative TCM and Western Medicine for Breast Cancer

Clinical Observational Studies: Breast Cancer Treatment by Traditional Chinese and Western Medicine

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Enrollment

200 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

Summary

The aim of this study is to investigate the intervention of traditional Chinese medicine (TCM) in managing the side effects experienced by breast cancer patients undergoing conventional Western medical treatments, such as blood cell decline, nausea, vomiting, gastrointestinal discomfort, and overall quality of life. The study aims to establish a long-term clinical enrollment criteria and process for TCM adjuvant therapy in breast cancer. The research design will utilize a prospective cohort study and real-world cross-sectional observational research method to obtain clinical data and survival status of the patients.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

A. Aged 18 years or above.
B. Female patients diagnosed with primary breast cancer and receiving Western medical treatment. The included breast cancer diagnosis codes based on ICD-9 are 174 to 179.

Exclusion Criteria3

A. Patients with a prior diagnosis of other malignant tumors before being diagnosed with primary breast cancer.
B. Patients with primary breast cancer who have not received Western medical treatment, meaning they have not undergone surgical resection, radiation therapy, chemotherapy, or targeted therapy..
C. After taking Chinese medicine, those who have uncomfortable symptoms or whose behavior affects Western medicine treatment should withdraw from the trial.

Interventions

DRUGChemotherapy drug

Participants in the standard care group receive conventional chemotherapy for breast cancer according to clinical guidelines. Treatment includes 8 cycles of chemotherapy administered every 3 weeks. No Traditional Chinese Medicine (TCM) is provided in this group.

OTHERIntegrative Treatment (Chemotherapy + TCM)

Participants in the integrative care group receive conventional chemotherapy combined with Traditional Chinese Medicine (TCM) treatment. Herbal formulas are prescribed by licensed TCM physicians based on syndrome differentiation and are aimed at strengthening vital qi and harmonizing stomach function. Treatment is conducted under Taiwan's National Health Insurance coverage.