Efficacy and safety of Buzhong Yiqi Decoction in improving cancer-related fatigue and immunity of cervical carcinoma patients: A protocol of randomized controlled trial

BACKGROUND: Cancer-related fatigue (CRF) is essentially universal in cervical carcinoma patients. It develops rapidly, with physical and mental manifestations including generalized weakness, diminished concentration or attention, and it has a negative impact in overall quality of life. Buzhong Yiqi Decoction (BYD), a classical Chinese medical prescription, could be used for allergic rhinitis, gut microbiota disorders, and chronic obstructive pulmonary disease. We preliminarily found that BYD could relieve CRF in cervical carcinoma patients. However, there are few trials on whether BYD could relieve CRF and improve immunity in cervical carcinoma patients. METHODS: This is a double-blinded, randomized, controlled clinical trial. From December 1, 2021 to May 31, 2022, cervical carcinoma patients with CRF will be assessed for randomization into treatment group (BYD) and control group (BYD simulation) in a 1:1 ratio. The outcomes are cancer fatigue scale, self-rating anxiety scales, self-rating depression scales, Pittsburgh sleep quality index, and immunity index (CD3(+), CD4(+), and CD8(+)) before and after the treatment. Statistical analysis will be performed using SPSS v22.0 software. RESULTS AND CONCLUSIONS: The study will clarify the efficacy and safety of BYD in improving CRF and immunity in cervical carcinoma patients. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/QFNMD.