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

Abstract

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.

• Authors: Haiyong Chen, Tsz Him So, William Chi-Shing Cho, Zongshi Qin, Chun Ho Ma, Shi Guang Li, Zhenjiang Yang, Fei Jiang, Junmei Wu, Zhang Jin Zhang, Feng Ming Kong, Lixing Lao
• Journal: Integrative cancer therapies (Integr Cancer Ther) 2021 Jan-Dec Vol. 20 Pg. 15347354211012749 ISSN: 1552-695X [Electronic] United States
• PMID: 33957783 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)

Topics

• Acupuncture Therapy
• Humans
• Neoplasms (therapy)
• Palliative Care
• Quality of Life
• Randomized Controlled Trials as Topic
• Treatment Outcome