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This 2-year trial is intended to be used to study breast cancer patients through forward-looking generation design through collaboration between Chinese and Western medical teams. The whole study consists of 2 stages, stage I comprises a cross-sectional study-baseline and stage II is a cohort for outcome evaluation and follow-up study across a 3-year period. To provide an empirical basis for combined TCM treatment in the Breast Cancer Research Team and to publish that as a reference for future TCM and Western medicine in integrative cancer treatment.
Breast cancer is a major health issue for women worldwide and has increased exponentially in the last decades. Improved earlier detection combined with adjuvant systemic therapy is responsible for much of the reduction in cause-specific mortality from breast cancer. Chemotherapy after surgery can decrease the risk of recurrence and is often used as routine treatment in clinic. Because of the fact that a considerable number of patients seek for traditional Chinese medicine (TCM) during adjuvant chemotherapy, it is thus need to evaluate the correlation between TCM treatment and prognosis. The investigators design a single center, prospective cohort study began in November 2018 in Kaohsiung, Taiwan. A sample of 104 participants diagnosed with early breast cancer was recruited from Breast Cancer Research Team and are followed up every 3 to 6 months till October 2023. Detailed information of participants includes general information, history of cancer, quality of life, side effects of chemotherapy and safety of treatment, body constitution of TCM and meridian energy analysis is taken face-to-face at baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | adjuvant chemotherapy combined with Chinese herbal medicine |
| |
| Cohort 2 | adjuvant chemotherapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese herbal medicine | Combination Product | All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | 3-year disease-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| QOLs measurement-1 | Functional Assessment of Cancer Therapy - Breast Cancer(FACT-B) | 6 months |
| QOLs measurement-2 | Eastern Cooperative Oncology Group (ECOG) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with breast cancer aged over 20 years with histologically diagnosed stage 1-3 after radical surgery are enrolled from an academic medical center. All participants need to complete the 6-8 cycle of adjuvant chemotherapy, which may last 6 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yen Tsai, PhD | Contact | +886975056534 | missuriae@yahoo.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chien-Ting Liu, MD | Division of Oncology, Department of Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | 83301 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41317109 | Derived | Chin CY, Wu SC, Wang HY, Liu CT, Huang YC, Tsai MY. Efficacy of Chinese Herbal Medicine in Managing Hot Flushes in Breast Cancer Patients on Adjuvant Chemotherapy: A Clinical Investigation. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251398843. doi: 10.1177/15347354251398843. Epub 2025 Nov 29. | |
| 31847861 | Derived |
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The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 6 months |
| TCM pattern | Body Constitution Questionnaire (BCQ) | 6 months |
| meridian energy | Meridian Energy Analysis Device (MEAD) | 6 months |
| Side effects of adjuvant chemotherapy | Common Terminology Criteria for Adverse Events (CTCAE) | 6 months |
| Liu CT, Chen YH, Huang YC, Chen SY, Tsai MY. Chemotherapy in conjunction with traditional Chinese medicine for survival of patients with early female breast cancer: protocol for a non-randomized, single center prospective cohort study. Trials. 2019 Dec 17;20(1):741. doi: 10.1186/s13063-019-3848-8. |
| D017437 |
| Skin and Connective Tissue Diseases |