Zhengyuan capsule for the treatment of cancer-related fatigue in lung cancer patients undergoing operation: study protocol for a randomized controlled trial

Abstract Background: Cancer-related fatigue (CRF) is one of the most common and painful symptoms in patients with lung cancer undergoing treatment with operation, affecting patients’ physical, psychological, family and social functions as well as their quality of life. However, there is very little evidence for treatment guidelines at home and abroad. Traditional Chinese Medicine (TCM) has been proved to improve the symptoms of general weakness and shown to be beneficial to cancer patients’ recovery. TCM treatment should be based on syndrome differentiation. Aiming at the CRF, we should focus on bolstering the deficiency while simultaneously attacking and reinforcing it. This trial preliminarily evaluated the efficacy and safety of Zhengyuan capsule for CRF in lung cancer patients undergoing operation. Methods/design: The single center clinical study is a two-group, double-blind, prospective, placebo-controlled, randomized controlled trial (RCT) designed to assess the efficacy and safety of Zhengyuan capsule for CRF in lung cancer patients undergoing operation. Eligible participants will randomly divided into two groups: a treatment group receiving a 8-week Zhengyuan capsule regimen therapy and a control group receiving a 8-week placebo capsule regimen therapy. The main efficacy indicator is fatigue, assessed using severity scores from the Cancer Fatigue Scale(CFS) measurement system. Secondary efficacy measures include fatigue which assessed using severity scores from the Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF) measurement system, TCM syndrome pattern differentiation, levels of immunologic indicators(TNF-α, IL-6, IL-1, T lymphocytes subsets and B lymphocyte subsets), patient’s pulmonary functionality and adverse events (AEs). Evaluation will be carried out at the screening period, baseline, the middle of the intervention and the end of the intervention, respectively. Discussion: Experimental results of Zhengyuan capsule can guide the improvement of CRF and provide evidences that Zhengyuan capsule is effective and safe in lung cancer patients undergoing operation. The data can be imported into the management and treatment guidelines of CRF for patients with lung cancer undergoing operation throughout China nationwide. Trial registration: Chinese Clinical Trial Registry (chictr.org.cn), ChiCTR1900022712/YZJ-TCM-ZYJN-02. Registered on 23 April 2019.