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

Not Applicable

Recruiting

Conditions: Not Applicable

Registration Number: KCT0001197

Lead Sponsor: Korea Ginseng Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 438

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake of trial drugs up to 8 weeks;Change in Functional Assessement of Chronic Illness Therapy-Fatigue Trial Outcome Index (FACIT-F TOI) after 8 and 16 weeks of trial drug intake;Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score after 8 and 16 weeks of trial drug in take;The percentage of subjects whom the Fuctional Assessment of Cancer Therapy-General (FACT-G) score decreased more than 20 scores after 8 and 16 weeks of trial drug intake;Change in blood cytokine(IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake;Change in blood cortisol level after 16 weeks of trial drug intake;Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake;adverse events