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
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)
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
Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Other: Placebo
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