Jin Won Kim1, Sae Won Han2, Jae Yong Cho3, Ik-Joo Chung4, Jong Gwang Kim5, Kyung Hee Lee6, Keon Uk Park7, Sun Kyung Baek8, Sang Cheul Oh9, Myung Ah Lee10, Doyeun Oh11, Byoungyong Shim12, Joong Bae Ahn13, Dongbok Shin14, Jae Won Lee15, Yeul Hong Kim16. 1. Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea. 2. Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. 3. Department of Internal Medicine, GangNam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. 4. Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, Republic of Korea. 5. Department of Oncology/Hematology, Kyungpook National University School of Medicine, Daegu, Republic of Korea. 6. Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Republic of Korea. 7. Department of Internal Medicine, Keimyung University Dongsan Medical Center, College of Medicine, Keimyung University, Daegu, Republic of Korea. 8. Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University School of Medicine, Seoul, Republic of Korea. 9. Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea. 10. Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. 11. Department of Internal Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea. 12. Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Republic of Korea. 13. Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. 14. Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea. 15. Department of Statistics, Korea University, Seoul, Republic of Korea. 16. Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea. Electronic address: yhk0215@korea.ac.kr.
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.
RCT Entities:
BACKGROUND:Cancer-related fatigue (CRF) is a common symptom and has a negative impact on prognosis in cancerpatients. CRF could be improved by Korean red ginseng (KRG). PATIENTS AND METHODS: For this randomised and double-blinded trial, colorectal cancerpatients 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 cancerpatients, and reduced CRF compared with placebo.
Authors: Rahel S König; Werner C Albrich; Christian R Kahlert; Lina Samira Bahr; Ulrike Löber; Pietro Vernazza; Carmen Scheibenbogen; Sofia K Forslund Journal: Front Immunol Date: 2022-01-03 Impact factor: 8.786