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

Study Overview
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Brief Summary
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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)

Official Title
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A Study of Korean Red Ginseng for Evaluation of Improvement of Cancer-related Fatigue in Patients With Colorectal Cancer With Chemotherapy: A Randomized, Double-blind, Placebo-Controlled, Parallel, Multicenter Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: Korean Red Ginseng
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Korean Red Ginseng<br>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 | Dietary Supplement: Korean Red Ginseng<br>* Given Orally<br>|
| Placebo Comparator: Placebo<br>Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses. Intervention: Other: Placebo | Dietary Supplement: Placebo<br>* Given Orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake |  | Baseline, 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 | Voluntary reports of adverse events and collected reports of adverse events (agitation, anxiety, headache, insomnia, vomiting) Laboratory and physical test ECOG performance ECG | Baseline, 8 and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, cancer related fatigue, Korean red ginseng, chemotherapy