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Journal of Traditional Chinese Medicine >

2023 , Vol. 43 >Issue 2: 374 - 378

DOI: https://doi.org/10.19852/j.cnki.jtcm.20221226.002

Original articles

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

  • Ying GAO ,
  • Yao WANG ,
  • Hongchun CHEN ,
  • Ran YAN ,
  • Tao LIU ,
  • Jinhao ZENG ,
  • Zhuohong LI
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  • 1 Oncology Department, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China
    2 Galactophore Department, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China
    3 TCM Regulating Metabolic Diseases Key Laboratory of Sichuan Province, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China

Received date: 2021-12-11

  Accepted date: 2022-04-01

  Online published: 2023-03-14

Supported by

Study of Press Needle on Immune Function in Breast Cancer Patients after Radical Mastectomy(20ZL15);Enhancement of Scientific Research Capacity of “Hundred Talents Program”(20-Q17)

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Abstract

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.

Key words： breast cancer resection; immune function; press needle; study protocol

Cite this article

Ying GAO , Yao WANG , Hongchun CHEN , Ran YAN , Tao LIU , Jinhao ZENG , Zhuohong LI . 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[J]. Journal of Traditional Chinese Medicine, 2023 , 43(2) : 374 -378 . DOI: 10.19852/j.cnki.jtcm.20221226.002

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