The efficacy and safety of Kyung-Ok-Ko on cancer-related fatigue in lung cancer patients: Study protocol for a randomized, patients-assessor blind, placebo-controlled, parallel-group, single-center trial

BACKGROUND: Cancer-related fatigue (CRF) is a major symptom experienced by lung cancer patients receiving chemotherapy and radiation therapy. Since CRF has a multidimensional influence on cancer patients, they may experience physical weakening, a decline in cognitive function, and depression from emotional consequences. Kyung-Ok-Ko is used for improving fatigue or weak physical constitution. It is known to be effective in immune activation, reducing fatigue, and enhancing cognitive function. Although Kyung-Ok-Ko is clinically used for the treatment of CRF, its efficacy and safety against CRF in lung cancer patients are yet to be studied. Therefore, we aimed to investigate the efficacy and safety of Kyung-Ok-Ko. METHODS: This is a randomized, placebo-controlled, patients-assessor blind, parallel-group, single-center clinical trial. Lung cancer patients with CRF, after termination of chemo or radiation therapies, are randomized in a 1:1 ratio to receive either Kyung-Ok-Ko or placebo for 6 weeks. The primary outcome is Brief Fatigue Inventory (BFI). The secondary outcomes include Visual Analog Fatigue Scale (VAFS), Functional Assessment of Cancer Therapy (FACIT) Fatigue scale, Hospital Anxiety Depression Scale (HADS), Montreal Cognitive Assessment Korean version (MoCA-K), and Korean pattern identification questionnaire. Adverse events are evaluated by Common Terminology Criteria for Adverse Events (CTCAE). All outcomes and adverse events are assessed at the baseline, mid-treatment, post-treatment, and at 1-month follow-up. DISCUSSION: This study investigates whether Kyung-Ok-Ko can alleviate CRF in lung cancer patients. The results of this study will provide clinical evidence for the application of Kyung-Ok-Ko in the treatment of CRF in lung cancer patients. TRIAL REGISTRATION: Korean Clinical Trial Registry (http://cris.nih.go.kr; registration number: KCT000666). Trial status: Currently, participant recruitment is ongoing.