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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Korean Red Ginseng | Experimental | Patients receive oral Korean Red Ginseng twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Dietary Supplement: Korean Red Ginseng |
|
| Placebo | Placebo Comparator | Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Other: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Korean Red Ginseng | Dietary Supplement | Given Orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks | From Baseline up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake of trial drugs up to 8 weeks | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response after 8 and 16 weeks of trial drug intake | Baseline, 8 and 16 weeks | |
| Progressive-free survival (PFS) | up to 16 weeks | |
| Change in blood cytokine(IL-2, IL-8, IL-10) level after 16 weeks of trial drug intake |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea Ginseng Corporation | Shinseongdong | Daejeon | 305-805 | South Korea |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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| Placebo |
| Dietary Supplement |
Given Orally |
|
| 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 | 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 | Baseline, 8 and 16 weeks |
| Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake | Baseline, 16 weeks |
| Change in blood cortisol level after 16 weeks of trial drug intake | Baseline, 16 weeks |
| Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake | Baseline, 16 weeks |
| adverse events |
| Baseline, 8 and 16 weeks |
| Baseline, 16 weeks |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |