Effect of Acupuncture on Lung Cancer-Related Fatigue: Study Protocol for a Multi-center Randomized Controlled Trial

Abstract

Background Fatigue is one of the primary symptoms of lung cancer patients, with a prevalence of 88.0% in cancer survivors, and even higher post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue, however, randomized controlled trials of suitable sample size are limited. Method/Design This is a multi-center, patient-blind, randomized controlled trial (RCT). A total of 320 eligible patients will be recruited in four centers (Shanghai Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Chest Hospital and LongHua Hospital Shanghai University of Traditional Chinese Medicine) and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1ratio. Treatment will be given twice per week for 12 sessions. Treatment will consist of acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of Brief Fatigue Inventory-Chinese (BFI-C), the secondary outcomes will be measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Hamilton Rating Scale for Depression (HAMD). The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week and follow-ups), the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat (ITT) analysis will be used in this RCT. Discussion This trial protocol provides an example of clinical application for the management of lung cancer-related fatigue using acupuncture treatment. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment.