BACKGROUND
In recent years, advancements in cancer treatment have enabled cancer cell inhibition, leading to improved patient outcomes. However, the side effects of chemotherapy, especially leukopenia, impact patients’ ability to tolerate their treatments and affect their quality of life (QoL). Traditional Chinese medicine (TCM) is thought to provide complementary cancer treatment to improve the QoL and prolong survival time among patients with cancer. This study aims to evaluate the effectiveness of Chinese herbal medicine (CHM) as a complementary treatment for neutropenia prevention and immunity modulation during chemotherapy in patients with breast cancer.
OBJECTIVE
This study aims to evaluate the efficacy of CHM as an add-on therapy for neutropenia and immunomodulation in patients with breast cancer.
METHODS
We will conduct a real-world pragmatic clinical trial to evaluate the effectiveness of CHM as a supplementary therapy to prevent neutropenia in patients with breast cancer undergoing chemotherapy. Patients will be classified into CHM or non-CHM groups based on whether they received CHM during chemotherapy. Employing generalized estimating equations or repeated-measures ANOVA, we will assess differences in white blood cell counts, absolute neutrophil counts, immune cells, and PD-1 expression levels between the two groups.
RESULTS
The enrollment process began in September 2021 and stopped in December 2023. A total of 60 patients will be recruited. Data cleaning and analysis are expected to finish in the middle of 2024.
CONCLUSIONS
TCM is the most commonly used complementary medicine, which has been reported to significantly alleviate chemotherapy-related side effects. This study's findings may contribute to developing effective interventions targeting chemotherapy-related neutropenia among patients with breast cancer in clinical practice.
CLINICALTRIAL
This study was registered on the International Traditional Medicine Clinical Trial Registry (ITMCTR) website (ID: ITMCTR2023000054).