Abstract
10008 Background: Cancer-related fatigue(CRF) is a common and severe symptom in patients with cancer. The purpose of this study is to evaluate the anti-fatigue effect of Korean Red Ginseng(Steamed Panax ginseng C.A. Meyer) on patients with colorectal cancer. Methods: 438 colorectal cancer patients in treatment with mFOLFOX-6 regimen were randomly assigned to either the Korean Red Ginseng[KRG](n = 219) or placebo(n = 219) group and received 2,000 mg/day test substances for 16 weeks. The primary endpoint was the Area Under Curve(AUC) of Brief Fatigue Inventory(BFI) over 16 weeks. The AUC and change from the baseline were calculated. The frequency and types of adverse events were determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.0. Results: 438 colorectal cancer patients were enrolled from 15 institutions. Changes from the baseline in the global BFI were 78.54(Standard deviation [SD] = 16.91) in KRG group vs. 75.89(SD = 16.85) in placebo group at 16 weeks(P = 0.0363). Changes from the baseline in the Usual Fatigue were 76.15 (SD = 17.08) in KRG group vs. 73.08(SD = 17.03) in placebo group at 16 weeks(P = 0.0454). Changes from the baseline in the Mood were 80.46(SD = 17.16) in KRG group vs. 77.88(SD = 17.59) in placebo group at 16 weeks(P = 0.0086). Changes from the baseline in the Relations with Others were 82.09(SD = 17.49) in KRG group vs. 78.67(SD = 17.90) in placebo group at 16 weeks(P = 0.0080). Changes from the baseline in the Walking ability were 82.70(SD = 17.28) in KRG group vs. 80.77(SD = 16.47) in placebo group at 16 weeks(P = 0.0090). Changes from the baseline in the Enjoyment of life were 79.53(SD = 19.53) in KRG group vs. 77.51(SD = 18.02) in placebo group at 16 weeks(P = 0.0150). Toxicities per self-report and CTCAE grading did not differ statistically significantly between the groups. Conclusions: The data supports benefits of consuming 2,000 mg KRG water extract powder daily on CRF over 16-week period. There were no discernible toxicities associated with the treatment. More studies on mechanisms of KRG to guide its role in CRF improvement are needed. Clinical trial information: NCT02039635.
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