The Effects of Press Needle on Immune Function and Quality of Life Among Female Breast Cancer Patients After Radical Mastectomy: Study Protocol for a Randomised Controlled Trial

Background: 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.MethodsThis study will be a single-center, randomized and single-blinded trial. 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, and then they will be followed-up 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 (KPS) score and the EORTC core quality of life questionnaire (EORTC QLQ-C30). Safety and adverse events will be assessed at each visit. DiscussionThe 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 registrationChinese Clinical Trial Registry, ChiCTR2000040100. Registered on 21 November 2020.