The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: Study Protocol for a 3-Arm Randomized Trial

• Main Authors: Haiyong Chen PhD, Tsz Him So MD, William Chi-Shing Cho PhD, Zongshi Qin MMed, Chun Ho Ma PhD, Shi Guang Li MD, Zhenjiang Yang MD, Fei Jiang PhD, Junmei Wu PhD, Zhang Jin Zhang MD, PhD, Feng Ming Kong MD, PhD, Lixing Lao MD, PhD
• Format: Article
• Language: English
• Published: SAGE Publishing 2021-05-01
• Series: Integrative Cancer Therapies
• Online Access: https://doi.org/10.1177/15347354211012749

Background: Cancer is the second leading cause of death before the age of 70. Improved cancer survival has put increasing demands on cancer care. Palliative care is the specialized multi-disciplinary care providing relief from the pain, symptoms, and stress of serious illness. The study aims to evaluate the adjunctive effect of acupuncture for advanced cancer patients in a collaborative model of palliative care. Methods/Design: This is a single-blinded, randomized, sham-controlled trial. One hundred twenty advanced cancer patients undergoing palliative care will be randomized in a ratio of 2:1:1 to manual acupuncture plus standard care group (ASC), sham acupuncture plus standard care group (SSC), and standard care group (SC). Patients in ASC and SSC will receive 9 sessions of acupuncture or sham acupuncture for 3 weeks, and will be followed up for 2 months. The primary measure is the change from baseline score of the Edmonton Symptom Assessment System at 3 weeks. The secondary measures include the Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Insomnia Severity Index, Numeric Rating Scale, and European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care. Discussion: The finding of this trial will provide high-quality evidence on the adjunctive effect of acupuncture to standard care on advanced cancer patients undergoing palliative care. Trial Registration: Clinicaltrials.gov, NCT04398875 ( https://www.clinicaltrials.gov/ct2/show/NCT04398875 ), Registered on 21 May 2020.