The effect of contact needle therapy on fatigue in patients with cancer in palliative care: A study protocol for a randomized controlled trial

INTRODUCTION: Almost all patients with end-of-life cancer experience cancer-related fatigue; however, there are only a few known effective coping methods. OBJECTIVES: : We will conduct a prospective, multi-center, single-blinded randomized controlled study to evaluate the efficacy of acupuncture for cancer-related fatigue in patients with end-of-life cancer. METHODS: We will enroll 120 patients with cancer hospitalized in a palliative care unit or receiving consultation from a palliative care team in four hospitals. We will add acupuncture treatment; specifically, contact needle therapy (CNT), consisting of an intervention per week period to the usual care. The primary outcome measure will be the Cancer Fatigue Scale (CFS) score while the secondary outcome measures will be the Numerical Rating Scale (NRS) score for fatigue, pain, and salivary amylase levels. CONCLUSION: We will evaluate the possibility of using acupuncture therapy, that is, CNT, in relieving fatigue sensation in patients with advanced cancer. Trial registration: UMIN000028304, registered on July 21st, 2017; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032401