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

Study of Traditional Chinese Medicine Added to Usual Breast Cancer Treatment

Clinical Observational Studies:Integrative TCM and Western Medicine for Breast Cancer
Recruiting
18 years or above
Female
Phase N/A
200 participants needed
1 Location

Brief description of study

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.

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: 18 years or above
  • Gender: Female

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.

The purpose of this research study is to learn about using traditional Chinese medicine (TCM) along with usual Western medical treatment for women with primary breast cancer. The study focuses on side effects that can happen during cancer treatment, such as low blood cell counts, nausea, vomiting, stomach or bowel discomfort, and overall quality of life.

Participants will be in 1 of 2 groups. One group will receive usual Western medical treatment. The other group will receive usual Western medical treatment plus TCM treatment. Participants who choose integrated TCM treatment will be referred to a TCM outpatient clinic, where a TCM practitioner will prescribe TCM. Participants will continue follow-up visits at both the oncology clinic and the TCM clinic while receiving their treatments.

Participants in both groups will have blood tests before their next cancer treatment to assess effects. Participants will also fill out questionnaires before starting chemotherapy and before each research visit to evaluate symptoms and quality of life. A final evaluation will be done within 4 weeks after the last radiation or chemotherapy session. The Western medical treatments and TCM treatments received in this study are covered by health insurance, and participants do not need to pay additional fees.

Who can participate:
Adult women with primary breast cancer may be able to participate if they:

  • Are age 18 or older
  • Have primary breast cancer
  • Are receiving Western medical treatment for breast cancer (such as surgery, radiation therapy, chemotherapy, or targeted therapy)

Updated on 27 Jul 2026. Study ID: 12-XD-090

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