Prospective Cohort Study of Traditional Chinese Medicine for Survival of Patients With Early Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Clinical Outcome of Adjuvant Chemotherapy in Conjunction With Traditional Chinese Medicine in Breast Cancer Patients -a Observational Cohort Study

Conditions
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Early-stage Breast Cancer

Intervention / Treatment
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* Combination Product: Chinese herbal medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged > 20 years old female patients; Patients with histologically proven stage 1-3 breast cancer after surgery; The duration from the end of radical surgery to the beginning of the trail is less than 1 month; ECOG score is 0-2 points; Agreed to participate in this study and signed informed consent. Exclusion Criteria: Combined with inadequate heart, liver, kidney and hematopoietic function and other serious diseases; Pregnant and lactating women; Patients with a history of mental illness; Patients with distant metastasis and/or expected lifetime less than 3 months; Patients undergoing other medicinal herbs outside our hospital.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>adjuvant chemotherapy combined with Chinese herbal medicine | Combination Product: Chinese herbal medicine<br>* All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy<br>|
| Cohort 2<br>adjuvant chemotherapy only | Combination Product: Chinese herbal medicine<br>* All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | 3-year disease-free survival | 3 years | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traditional Chinese medicine, quality of life, disease-free survival, adjuvant chemotherapy, breast cancer