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Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial

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机构: [1]School of Public Health, Peking University, Beijing, China [2]Peking University Clinical Research Institutes, Beijing, China [3]Department of Acupuncture, Yantai Hospital of Traditional Chinese Medicine, Yantai, China [4]Department of Urology, Yantai Hospital of Traditional Chinese Medicine, Yantai, China [5]Department of Integrative Medicine, West China Hospital, Sichuan University, Chengdu, China [6]School of Chinese Medicine, Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, Hong Kong, Hong Kong SAR, China [7]Department of Medicine, Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York City, NY, USA [8]Department of Health Policy, Department of Clinical Epidemiology, National Center for Child Health and Development, Tokyo, Japan [9]Department of Urology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China [10]Department of Urology, China-Japan Friendship Hospital, Beijing, China [11]Department of Chinese Medicine, Shanghai East Hospital, Tongji University, Shanghai, China [12]Department of Urology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China [13]Department of Acupuncture, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
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关键词: Acupuncture Sham acupuncture Quality of life Prostate cancer Hot flashes Randomized controlled trial Study protocol

摘要:
Hot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence.Five hospitals will recruit 120 acupuncture naïve patients with moderate-to-severe hot flashes after prostate cancer received ADT in China from February 2023 to December 2024. Participants will be randomly 2:1:1 allocated to the 18 sessions of verum acupuncture at true acupuncture points plus usual care, 18 sessions of non-penetrating sham acupuncture at non-acupuncture points plus usual care, or usual care alone over 6 weeks. The primary outcome measure is the change of mean weekly hot flashes symptom severity score (HFSSS) at the end of treatment compared with baseline.We will be able to measure the effectiveness of acupuncture for patients with PCa suffering from ADT-induced hot flashes and whether acupuncture is superior to sham acupuncture and usual care. The proposed acupuncture treatment might provide an alternative option for those patients.Clinicaltrials.gov (NCT05069467).© 2023. The Author(s).

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大类 | 2 区 医学
小类 | 2 区 全科医学与补充医学
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大类 | 3 区 医学
小类 | 2 区 全科医学与补充医学
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Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE
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Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE

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第一作者机构: [1]School of Public Health, Peking University, Beijing, China [2]Peking University Clinical Research Institutes, Beijing, China
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