摘要
OBJECTIVE:To determine the difference in prevention of chemotherapy-induced fatigue between time-acupointsspace 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 multidimensional fatigue inventory(MFI)over the previous week and Visual Analogue Scale measuring fatigue(VAS-F),and to evaluate the effects of ATAS on selfreported neuropathy pain,sleep,anxiety and depression.METHODS:In this multicenter clinical trial,we have randomized patients into 3 groups:ATAS,Sham and nonacupuncture 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 stageⅠ-Ⅲbreast 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 chemotherapyinduced 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.
基金
Supported by PreciMed Platform Europe,a Financial Support from France Ruban Rose,the Pilot Clinical Study at Kunming Site was Granted By Yunnan Provincial Science and Technology Department Funding(No.2018IA059)。
