Colorectal Cancer
Conditions
Keywords
cancer, cancer related fatigue, Korean red ginseng, chemotherapy
Brief summary
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)
Interventions
DIETARY_SUPPLEMENTKorean Red Ginseng
Given Orally
DIETARY_SUPPLEMENTPlacebo
Given Orally
Sponsors
Korea Ginseng Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks | From Baseline up to 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of subjects whom the Functional Assessment of Cancer Therapy-General (FACT-G) score decreased more than 20 scores after 8 and 16 weeks of trial drug intake | Baseline, 8 and 16 weeks | — |
| Change in blood cortisol level after 16 weeks of trial drug intake | Baseline, 16 weeks | — |
| Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake | Baseline, 16 weeks | — |
| adverse events | Baseline, 8 and 16 weeks | * Voluntary reports of adverse events and collected reports of adverse events (agitation, anxiety, headache, insomnia, vomiting) * Laboratory and physical test * ECOG performance * ECG |
| Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake of trial drugs up to 8 weeks | From Baseline up to 8 weeks | — |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue Trial Outcome Index (FACIT-F TOI) after 8 and 16 weeks of trial drug intake | Baseline, 8 and 16 weeks | — |
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score after 8 and 16 weeks of trial drug in take | Baseline, 8 and 16 weeks | — |
| Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake | Baseline, 16 weeks | — |
Other
| Measure | Time frame |
|---|---|
| Change in blood cytokine(IL-2, IL-8, IL-10) level after 16 weeks of trial drug intake | Baseline, 16 weeks |
| Progressive-free survival (PFS) | up to 16 weeks |
| Tumor response after 8 and 16 weeks of trial drug intake | Baseline, 8 and 16 weeks |
Countries
South Korea
Outcome results
None listed