Korean red ginseng for cancer-related fatigue in colorectal cancer patients with chemotherapy: A randomised phase III trial

Jin Won Kim, Sae Won Han, Jae Yong Cho, Ik Joo Chung, Jong Gwang Kim, Kyung Hee Lee, Keon Uk Park, Sun Kyung Baek, Sang Cheul Oh, Myung Ah Lee, Doyeun Oh, Byoungyong Shim, Joong Bae Ahn, Dongbok Shin, Jae Won Lee, Yeul Hong Kim

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Abstract

Background: Cancer-related fatigue (CRF) is a common symptom and has a negative impact on prognosis in cancer patients. CRF could be improved by Korean red ginseng (KRG). Patients and methods: For this randomised and double-blinded trial, colorectal cancer patients who received mFOLFOX-6 were randomly assigned to either KRG 2000 mg/day (n = 219) or placebo (n = 219) for 16 weeks. CRF was evaluated using the mean area under the curve (AUC) change from baseline of brief fatigue inventory (BFI) as the primary endpoint. Fatigue-related quality of life, stress, and adverse events were evaluated as secondary endpoints. Results: In the full analysis group, KRG up to 16 weeks improved CRF by the mean AUC change from baseline of BFI compared to placebo, particularly in “Mood” and “Walking ability” (P = 0.038, P = 0.023, respectively). In the per-protocol group, KRG led to improved CRF in the global BFI score compared with the placebo (P = 0.019). Specifically, there were improvements in “Fatigue right now,” “Mood,” “Relations with others,” “Walking ability,” and “Enjoyment of life” at 16 weeks (P = 0.045, P = 0.006, P = 0.028, P = 0.003, P = 0.036, respectively). In subgroups of female patients, ≥60 years old, with high compliance (≥80%) or more baseline fatigue, the beneficial effects of KRG were more enhanced than that of placebo. Although neutropenia was more frequent in KRG than placebo, the incidence of all adverse events was similar. Conclusions: KRG could be safely combined with mFOLFOX-6 chemotherapy in colorectal cancer patients, and reduced CRF compared with placebo.

Original languageEnglish
Pages (from-to)51-62
Number of pages12
JournalEuropean Journal of Cancer
Volume130
DOIs
Publication statusPublished - 2020 May

Keywords

  • Cancer-related fatigue
  • Colorectal cancer
  • Korean red ginseng
  • mFOLFOX-6

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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  • Cite this

    Kim, J. W., Han, S. W., Cho, J. Y., Chung, I. J., Kim, J. G., Lee, K. H., Park, K. U., Baek, S. K., Oh, S. C., Lee, M. A., Oh, D., Shim, B., Ahn, J. B., Shin, D., Lee, J. W., & Kim, Y. H. (2020). Korean red ginseng for cancer-related fatigue in colorectal cancer patients with chemotherapy: A randomised phase III trial. European Journal of Cancer, 130, 51-62. https://doi.org/10.1016/j.ejca.2020.02.018