Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer
NCT ID: NCT02039635
Last Updated: 2017-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
438 participants
INTERVENTIONAL
2013-12-31
2017-03-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Korean Red Ginseng
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
Korean Red Ginseng
Given Orally
Placebo
Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses.
Intervention: Other: Placebo
Placebo
Given Orally
Interventions
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Korean Red Ginseng
Given Orally
Placebo
Given Orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Korea Ginseng Corporation
INDUSTRY
Responsible Party
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Locations
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Korea Ginseng Corporation
Shinseongdong, Daejeon, South Korea
Countries
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Other Identifiers
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KGC-S-02
Identifier Type: -
Identifier Source: org_study_id
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