Bojungikgi-tang for Anorexia in Colorectal Cancer Patients after Curative Resection and Chemotherapy: A Single-arm, Open-label, Single-center Trial

Objectives: This study evaluated the effectiveness and safety of Bojungikgi-tang for colorectal cancer patients with anorexia.Methods: This was a single-arm, open-label, and single-center trial, and suitable participants took the test drug (Bojungikgi-tang) three times a day before or between meals for six weeks (42 days). After registration of clinical trials (visit 2), they visited the hospital every three weeks (visits 3 and 4) and measured or tested the effectiveness or safety evaluation variables to analyze the results. The primary outcome was the anorexia/cachexia subscale (A/CS) of functional assessment of anorexia/cachexia therapy (FAACT) score.Results: Eleven colorectal cancer patients were included in the ITT analysis. Colorectal cancer patients had significantly higher A/CS of FAACT scores after six weeks of Bojungikgi-tang administration compared to that at the baseline (p=0.0006). In the secondary outcomes, functional assessment of cancer therapy for patients with colorectal cancer (FACT-C) (p=0.0343) and the VAS score of anorexia (p<0.0001) showed a significant improvement after six weeks of treatment. No serious adverse events were associated with Bojungikgi-tang in colorectal cancer patients.Conclusion: Bojungikgi-tang can be an effective and safe treatment for anorexia in colorectal cancer patients after curative resection and chemotherapy.