Preliminary study on efficacy and safety of Kyung-Ok-Ko on cancer fatigue in lung cancer patients during cancer treatment - randomized, double blind, placebo controlled, parallel, single center investigator clinical trial

Kyung Hee University Oriental Medical Center0 个研究点目标入组 50 人开始时间: 待定最近更新: 2019年4月23日

适应症

试验速览

暂无简介。

•1) Men and women aged 19-75 years old
•2) Lung cancer patients who received cancer treatment (Chemo and radiation therapy)
•3) Patients who have completed cancer treatment over 2 weeks ago and do not have further cancer treatment plan
•4) Patients experiencing fatigue with BFI >4
•5) Patients with Eastern Cooperative Oncology Group (ECOG) scale <2
•6) Patients who voluntarily decided to participate in this clinical trial and signed the consent form

•1) Patients suspected of relapse or progression according to chest CT or Chest Xray
•2) Patients with anemia with hemoglobin level <9 g/dL, or platelets <50 000/mL, or absolute neutrophil with count <1000/mL
•3) Patients with uncontrolled thyroid disorder (hyperthyroidism fT4 > 1.79 ng/dL, hypothyroidism Thyroid Stimulating Hormone > 10?/dL)
•4) Patients with moderate liver and kidney impairment (increase in AST and ALT by more than 3 times, or increase in creatinine by more than 2 times)
•5) Patients who do not expect more than 6 months of life expectancy for cancer diagnosis
•6) Patients diagnosed and treated for severe dementia (MoCA < 10), severe depression (HADS >15)
•7) Patients who are deemed difficult to perform clinical trial
•8) Early stage lung cancer patients who are treated with surgery alone and late stage lung cancer patients who are not receiving cancer treatment
•9) Patients who received oriental medicine or pharmacotherapy (methylphenidate, modafinil, bupropion) for the purpose of improving cancer fatigue in the last 4 weeks
•10) Patients who are pregnant or breastfeeding
•11) Patients who did not agree to contraception during the clinical trial period
•12) Patients who participated in a clinical trial for the same disease in the last 3 months
•13) Patients who are not eligible to participate in this trial at the discretion of the investigator

发起方

Kyung Hee University Oriental Medical Center