A study of Korean red ginseng for evaluation of improvement on cancer-related fatigue in patients with colorectal cancer with chemotherapy: A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Trial

Korea Ginseng Corporation0 个研究点目标入组 438 人开始时间: 待定最近更新: 2019年3月11日

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•1) 20 years and older
•2) Person who agreed to participate in this study and signed voluntarily on the written informed consent form
•3) Person who is confirmed as colorectal cancer through histological and image diagnosis and scheduled for adjuvant or palliative therapy with mFOLFOX-6 regimen
•4) Fertile patients with negative pregnancy test confirmed and who has agreed to use effective contraception
•5) Person who is able to fully communicate with the physician about his/her fatigue status and is able to completely fill out the questionnaires
•6) Life expectancy more than 6 months
•7) Performance status of Eastern Cooperative Oncology Group grade 0~1
•8) Hemoglobin = 9g/dL
•9) Person with moderate liver funtion(Alkaline phosphatase, Alanine aminotransferase = 2.5 X Upper Limit of Normal)
•10) Person with moderate renal function(Creatine = 1.5 × Upper Limit of Normal)

•1) Pregnant or nursing women
•2) Primary brain cancer, brain metastases or other Central Nervous System malignancy, including Central Nervous System lymphoma
•3) No controlled pain despite the use if analgesics.
•4) Person showing hypothyroidism despite the hormone treatment
•5) Person with insomnia despite an appropriate treatment
•6) No controlled hypertension (Disstolin Blood Pressure>100mmHg ?? Systolic Blood Pressure>160mmHg)
•7) Person who has experience of hypersensitivity to the trial drug(ginseng) componens
•8) Person with autoimmune disorders(Multiple sclerosis, Lupus, rheumarthritis etc)
•9) Person who is alcoholic dependent or has psychiatric disorder
•10) Person who has cognitive or psychiatric problems
•11) Person who has an experience of chemotherapy agents use 6 months before a screening visit
•12) Person who had a surgery 2 weeks before a screening visit
•13) Person who had taken herbal medicinal product (including chinese medicine) 4 weeks before the screening visit
•14) Person who has medical status that is judged to affect the result or who is judged as inappropriate for the study by the physician

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