NCT02039635已完成不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
Patients receive oral placebo twice daily for 16 weeks. Treatment repeats every 4 weeks for 4 courses.
Intervention: Other: Placebo
干预措施: Placebo (Dietary Supplement)
Korean Red Ginseng
Experimental
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
干预措施: Korean Red Ginseng (Dietary Supplement)
结局指标
主要结局
Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks
时间窗: From Baseline up to 16 weeks
次要结局
- 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(Baseline, 8 and 16 weeks)
- 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)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic DiseaseSjögren's SyndromeRheumatic DiseasesKorean Red GinsengNCT03983408Hanyang University120
已完成
4 期
Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic HepatitisFatigueNCT02331589Chuncheon Sacred Heart Hospital75
已完成
4 期
The Effect of Korean Red Ginseng Supplementation on Glucose ControlDiabetesNCT01911663Yonsei University60
Unknown
不适用
A Clinical Study About Improvement of Chronic Fatigue After Taking Red GinsengChronic Fatigue SyndromeNCT02847845Eun Jung Kim50
已完成
2 期
Effect of Korean Red Ginseng on Oxidation in Middle-aged and Elderly Sub-health PopulationHealthy AgeingAntioxidative StressNCT05592093Shanghai Jiao Tong University School of Medicine900