Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer

Launched by KOREA GINSENG CORPORATION · Jan 15, 2014

Keywords

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Gender

ALL

Eligibility criteria

• 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