Efficacy of press needle on immune function and quality of life in female breast cancer patients after radical mastectomy: study protocol for a randomized controlled trial.

Radical mastectomy may lead to suppression of cellular immune function in patients with malignant tumors, and affect the quality of life (QOL) of patients. Immune suppression is a common cause of complications and adverse reactions in adjuvant therapy after radical mastectomy of breast cancer. Currently, there are few proven effective treatments for immune suppression. Therefore, it's necessary to develop a new treatment method. Press needle is widely used in clinical practice. However, there have been relatively few studies that evaluate the effects of press needle on postoperative immune function. The aim of the present study is to assess the effects of press needle on immune function and QOL in female breast cancer patients undergoing radical mastectomy. This study will be a single-center, randomized and single-blinded trial. Totally 78 eligible patients will be randomized in a ratio of 1:1 to the press needle group or the sham press needle group. During the treatment phase, patients will undergo five times weekly of verum press needle or sham press needle for 2 weeks. The primary outcome measures will be the peripheral blood levels of CD8+, CD4+, CD3+, and CD4+/CD8+ T cells. The secondary outcome measures will be the changes of patients' QOL, evaluated by the Karnofsky Performance Scale score and the EORTC core quality of life questionnaire (EORTC QLQ-C30). Furthermore, 5-year survival rate and recurrence rate will be evaluated. Safety and adverse events will be assessed at each visit. The results of this on-going study will provide clinical evidence for the effects and safety of press needle on immune function and QOL in patients after breast cancer resection compared with sham press needle. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000040100. Registered on 21 November 2020.

A randomized controlled study on the prevention and treatment of radiation-induced oral mucositis by Chinese herbal compound prescription / 中华放射医学与防护杂志

Objective:To evaluate the efficacy and safety of the combination of conventional western medicine therapy and oral traditional Chinese medicine (TCM) compound in the prevention and treatment of radiotherapy-inducedoral mucositis (RTOM) of nasopharyngeal carcinoma patients treated with concurrent radiotherapy and chemotherapy.Methods:A randomized, single-center, and open-label controlled experiment was conducted. Software Stata was used to generate random numbers, and 100 subjects were randomly assigned to two groups ata 1∶1 ratio, namely the integrated Chinese and western medicine group(the integrated group) and the conventional western medicine group. This study focused on the incidence of level-ⅢRTOM, followed by these verity degree of RTOM, therisk of malnutrition, and safety.Results:The incidences of level-III RTOM in the integrated group and the conventional western medicine group were 18% and 46%, respectively, with a statistically significant difference ( χ2=9.007, P=0.003). Compared to the integrated group, the conventional western medicine group showed a significantly increase dseverity degree of RTOM ( OR=3.269, 95% CI: 1.627-6.567, P<0.001) and higher risk of malnutrition ( OR=3.021, 95% CI: 1.786-5.109, P<0.001). Moreover, compared to the integrated group, the conventional western medicine group showed decrease dincidence of thirst (48.97% and 72.00% respectively; χ2=5.493, P=0.019) and decreased incidence of neutrophilcount reduction(12.24% and 30.00%, respectively, χ2=4.668, P=0.031). The incidence of mild/moderate adverse events related to TCM compound was 4.08%(2/49), and no serious adverse events related to TCM compound were observed. Conclusions:Compared to the conventional western medicine regimen, the integrated Chinese and western medicine regimen IS more effective in the prevention and treatment of RTOM. Meanwhile, its clinical application is safe and reliable.