Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether Korean Red Ginseng is effective compared with a placebo in chemotherapy. The purpose of this study is to determine whether Korean Red Ginseng is effective in the treatment of the fatigue from colorectal cancer with chemotherapy.(modified FOLFOX-6)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
438
Given Orally
Given Orally
Korea Ginseng Corporation
Shinseongdong, Daejeon, South Korea
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks
Time frame: From Baseline up to 16 weeks
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake of trial drugs up to 8 weeks
Time frame: From Baseline up to 8 weeks
Change in Functional Assessment of Chronic Illness Therapy-Fatigue Trial Outcome Index (FACIT-F TOI) after 8 and 16 weeks of trial drug intake
Time frame: Baseline, 8 and 16 weeks
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score after 8 and 16 weeks of trial drug in take
Time frame: Baseline, 8 and 16 weeks
The percentage of subjects whom the Functional Assessment of Cancer Therapy-General (FACT-G) score decreased more than 20 scores after 8 and 16 weeks of trial drug intake
Time frame: Baseline, 8 and 16 weeks
Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake
Time frame: Baseline, 16 weeks
Change in blood cortisol level after 16 weeks of trial drug intake
Time frame: Baseline, 16 weeks
Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake
Time frame: Baseline, 16 weeks
adverse events
* Voluntary reports of adverse events and collected reports of adverse events (agitation, anxiety, headache, insomnia, vomiting) * Laboratory and physical test * ECOG performance * ECG
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Time frame: Baseline, 8 and 16 weeks