Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT02039635
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02039635
Study Brief:
Protocol Section:
NCT02039635