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

Buddhist Tzu Chi Medical Foundation

Status: Enrolling

Conditions: Breast Cancer

Treatments: Drug: Chemotherapy drug; Other: Integrative Treatment (Chemotherapy + TCM)

Study type: Observational

Funder types: Other

Identifiers

NCT07096180

12-XD-090

Details and patient eligibility

About

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.

Full description

Two-group parallel experimental design. One group received conventional Western medicine treatment, while the other group received combined treatment with both traditional Chinese and Western medicine treatment.

A. Patients who opt for integrated traditional Chinese medicine (TCM) treatment will be referred to the TCM outpatient department, where a TCM practitioner will prescribe TCM prescriptions, followed by the initial clinical effectiveness assessment.

B. Patients will continue their follow-up visits at the oncology and TCM clinics, receiving both conventional Western medicine treatments and TCM treatments.

C. Both the Western medicine treatments and TCM treatments received by the patients are covered by health insurance, and patients do not need to pay anyadditional fees.

D. Both the "Conventional Western Medicine Treatment Group" and the "Integrated Western and Chinese Medicine Treatment Group" will undergo another clinical effectiveness assessment (blood tests) before the next cancer treatment.

E. A questionnaire will be administered before starting chemotherapy and before each research visit for treatment evaluation. A final evaluation will be conducted within four weeks after the last radiation or chemotherapy session. The questionnaire includes the EOG, BFI-T, FACT-B,EORTC-QLQ-C30, EORTC-QLQ-BR23, WHOQOL-BREF, and BCQ.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

200 participants in 2 patient groups

Conventional Western Medicine Treatment Group

Description:

Patients receive standard Western medical care, including chemotherapy, according to clinical guidelines. No Traditional Chinese Medicine (TCM) is involved. Clinical assessments and questionnaires are administered throughout the treatment course.

Treatment:

Drug: Chemotherapy drug

Integrative Treatment Group (Western Medicine + TCM)

Description:

Patients receive both standard Western medical care (e.g., chemotherapy) and Traditional Chinese Medicine (TCM) treatments. TCM is prescribed based on syndrome differentiation and focuses on supporting healthy qi and mitigating side effects. Clinical assessments and questionnaires are administered throughout the treatment course.

Treatment:

Other: Integrative Treatment (Chemotherapy + TCM)