Abstract
BackgroundChemotherapy after surgery for breast cancer plays a fundamental role in reducing the risk of distant and local recurrence. An increasing number of patients seek traditional Chinese medicine (TCM) during adjuvant chemotherapy to relieve symptom discomfort and side effects as well as to strengthen the body’s defenses. However, evidence on how concurrent TCM treatment affects prognosis is scarce. This trial aims to evaluate the association between TCM treatment and disease-free survival outcomes for patients with early breast cancer who are undergoing adjuvant chemotherapy.Methods/designThis is a non-randomized, single center, prospective cohort study begun in November 2018 in Kaohsiung, Taiwan. A sample of 310 participants diagnosed with early breast cancer was recruited from the Breast Cancer Research Team and will be followed up every 3 to 6 months until October 2023. Detailed information of the participants, including general information, history of cancer, quality of life, side effects and safety of treatment, TCM body constitution, and meridian energy analysis, was collected face to face at baseline.DiscussionThis is the first prospective observational cohort study on TCM in patients with early breast cancer who are receiving adjuvant chemotherapy to evaluate the prognosis. Through this trial, we hope to assess the feasibility of a larger-scale clinical trial in the future and formulate an integrated TCM care program.Trial registrationClinicalTrials.gov, NCT03797248. Registered on 5 January 2019.
Highlights
Chemotherapy after surgery for breast cancer plays a fundamental role in reducing the risk of distant and local recurrence
We hope to assess the feasibility of a larger-scale clinical trial in the future and formulate an integrated traditional Chinese medicine (TCM) care program
According to a relevant large-scale cohort study [21], the 3-year disease-free survival (DFS) rate of patients with early breast cancer after surgery is about 85%, and we expect it to increase to 95% with Chinese herbal medicine (CHM) treatment
Summary
Chemotherapy after surgery for breast cancer plays a fundamental role in reducing the risk of distant and local recurrence. Evidence on how concurrent TCM treatment affects prognosis is scarce. This trial aims to evaluate the association between TCM treatment and disease-free survival outcomes for patients with early breast cancer who are undergoing adjuvant chemotherapy. Chemotherapy plays an important role in the systemic treatment of breast cancer, and it is the cornerstone of therapy for patients who are not candidates for hormone therapy [3]. After breast surgery, National Comprehensive Cancer Network (NCCN) guidelines specify only adjuvant chemotherapy to eliminate remaining cancer cells and improve survival in most patients with early stage breast cancer [5, 6].
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