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

Chien-Ting Liu, Yen-Hao Chen, Yu-Chuen Huang, Shih-Yu Chen, Ming-Yen Tsai, Chien-Ting Liu, Yen-Hao Chen, Yu-Chuen Huang, Shih-Yu Chen, Ming-Yen Tsai

Abstract

Background: Chemotherapy 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/design: This 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.

Discussion: This 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 registration: ClinicalTrials.gov, NCT03797248. Registered on 5 January 2019.

Keywords: Breast cancer; Disease-free survival; Quality of life; Study design; Traditional Chinese medicine.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the study. The safety assessment contains a routine blood test, kidney function test, and liver function test. BCQ Body Constitution Questionnaire, CHM Chinese herbal medicine, CTCAE Common Terminology Criteria for Adverse Events (version 4), ECOG Eastern Cooperative Oncology Group (score), FACT-B Functional Assessment of Cancer Therapy - Breast Cancer, MEAD Meridian Energy Analysis Device, TCM traditional Chinese medicine

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