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. 2022 Apr;42(2):289-295.
doi: 10.19852/j.cnki.jtcm.2022.02.008.

An international multicentric phase Ⅲ randomized controlled trial of time-acupoints-space acupuncture for the prevention of chemotherapy-induced fatigue in patients with early stage breast cancer: a study protocol

Saghachian Mahasti  1 , Barry Caroline  2 , Asselain Bernard  3 , L I Yunfen  4 , Nie Jianyun  4 , Liu Dequan  4 , Chen Dedian  4 , Chen Chunxin  5 , Laura Estevez  5 , L I Wenhui  4 , Jean-Pierre Armand  1 , Zhu Miansheng  6   7 , J U Liya  8
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An international multicentric phase Ⅲ randomized controlled trial of time-acupoints-space acupuncture for the prevention of chemotherapy-induced fatigue in patients with early stage breast cancer: a study protocol

Saghachian Mahasti et al. J Tradit Chin Med. 2022 Apr.

Abstract

Objective: To determine the difference in prevention of chemotherapy-induced fatigue between time-acupoints-space acupuncture (ATAS) administered weekly compared to sham acupuncture and non-acupuncture in patients with early breast cancer receiving adjuvant chemotherapy by epirubicine-cyclophosphamide (EC) followed by paclitaxel, as measured by the multi-dimensional fatigue inventory (MFI) over the previous week and Visual Analogue Scale measuring fatigue (VAS-F), and to evaluate the effects of ATAS on self-reported neuropathy pain, sleep, anxiety and depression.

Methods: In this multicenter clinical trial, we have randomized patients into 3 groups: ATAS, Sham and non-acupuncture with an unequal randomization of 2∶1∶1. A cloud related electronical clinical report form and smartphone platform was established for data entry. Patients with a history of stage Ⅰ-Ⅲ breast cancer scheduled to receive adjuvant chemotherapy. Acupuncture will be delivered once a week during chemotherapy with VAS-F evaluation. In order to qualify and quantify the mechanism of fatigue induced by chemotherapy with or without acupuncture, an evaluation of immune profiling was incorporate in this study.

Results: The presence and seriousness of chemotherapy-induced fatigue should be considered in therapeutic programs for early breast cancer treatment. Fatigue induced by adjuvant chemotherapy in patients with breast cancer remains a major concern affecting the quality of life significantly. Unfortunately, we do not have effective pharmacological interventions yet. And clinical trials of acupuncture in preventing chemotherapy-induced fatigue in patients with early breast cancer have not been reported.

Conclusion: The findings of the trial will allow us to determine the effects of acupuncture treatment approach. We will also be able to confirm whether ATAS is better than sham acupuncture and non-acupuncture treatments.

Keywords: breast neoplasms; chemotherapy, adjuvant; clinical protocols; fatigue; immunity; time-acupoints-space acupuncture.

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Figures

Figure 1
Figure 1. Study design
Figure 2
Figure 2. Basic protocol of time-acupoints-space acupuncture
Figure 3
Figure 3. Schema of Sham acupuncture
See this image and copyright information in PMC

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