Clinical trial · Interventional
Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer
A Study of Korean Red Ginseng for Evaluation of Improvement of Cancer-related Fatigue in Patients With Colorectal Cancer With Chemotherapy: A Randomized, Double-blind, Placebo-Controlled, Parallel, Multicenter Trial
NCT02039635CI-TRIAL-00029039KRGcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Korean Red Ginseng | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Korean Red Ginseng
- description
- 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
- interventionNames
- Dietary Supplement: Korean Red Ginseng
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Other: Placebo
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
- Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 20 years and older * Person who agreed to participate in this study and signed voluntarily on the written informed consent form * Person who is confirmed as colorectal cancer through histological and image diagnosis and scheduled for adjuvant or palliative therapy with mFOLFOX-6 regimen * Fertile patients with negative pregnancy test confirmed and who has agreed to use effective contraception * Person who is able to fully communicate with the physician about his/her fatigue status and is able to completely fill out the questionnaires * Life expectancy more than 6 months * Performance status of ECOG grade 0\~1 * Hb ≥ 9g/dL * Person with moderate liver function (AST, ALT ≤ 2.5 × ULN) * Person with moderate renal function (Cr ≤ 1.5 × ULN) Exclusion Criteria: * Pregnant or nursing women * Primary brain cancer, brain metastases or other CNS malignancy, including CNS lymphoma * No controlled pain despite the use if analgesics. * Person showing hypothyroidism despite the hormone treatment * Person with insomnia despite an appropriate treatment * No controlled hypertension (DBP \>100mmHg or SBP \>160mmHg) * Person who has experience of hypersensitivity to the trial drug (ginseng) components * Person with autoimmune disorders (Multiple sclerosis, Lupus, rheumarthritis etc.) * Person who is alcoholic dependent or has psychiatric disorder * Person who has cognitive or psychiatric problems * Person who has an experience of chemotherapy agents use 6 months before a screening visit * Person who had a surgery 2 weeks before a screening visit * Person who had taken herbal medicinal product (including Chinese medicine) 4 weeks before the screening visit * Person who has medical status that is judged to affect the result or who is judged as inappropriate for the study by the physician
References
Publications (0)
Data not yet available
No reference posted for this study.