A pilot study investigating the effect of multivitamin and mineral complex on natural killer cell activity in surgically resected non-small cell lung cancer patients

Kyung Hee University Hospital0 个研究点目标入组 66 人开始时间: 待定最近更新: 2023年1月10日

适应症

试验速览

暂无简介。

•1) Male or female adult patients aged 19 years old and above
•2) Histologically confirmed stage I, II, IIIA NSCLC patients according to TNM classification for lung cancer of the International Association, 8th edition
•3) ECOG performance status 0~2
•4) Patients without other organ failure and Lung-resectable on the basis of cardiac and pulmonary function tests
•5) Adequate kidney and liver function:
•-Total bilirubin = 1.25 X UNL
•-AST(SGOT) ? ALT(SGPT) = 3.0 X UNL
•-Alkaline phosphatase = 2.5 X UNL
•-Serum creatinine = 1.5 X UNL
•6) Patients who are able to comply with the protocol and provide written informed consent for the study voluntarily
•7) Patients who agree that other health supplements, multivitamin and mineral complex, agaricus mushroom and related health functional foods are not allowed during the study period

•1) Patients with malignancies other than NSCLC
•2) Patients who have undergone surgery within 5 years for other malignancies, with the exception of skin cancer(excluding melanoma) and thyroid cancer
•3) Patients who have recieved more than 5mg/day prednisone or equivalent corticosterod within the last month or anticipated requirement for immunosuppressive medications during the study period
•4) Patients with prior allogenic stem cell or solid organ transplantation
•5) Patients with active acute infection or uncontrolled inflammatory lung disease
•But patinets with controlled and stable chronic lung disease may be eligible for the study in the opinion of the investigator.
•6) Patients with autoimmune diseases or severe systemic diseases that is ineligible for the study participation
•7) Patients with histories of mental disorder, alcoholism or drug abuse that could affect the study participation
•8) Patients who is inappropriate for the study subject according to the investigator’s judgment
•9) Women of childbearing potential
•10) Pregnant and lactating women
•11) Illiterate

发起方

Kyung Hee University Hospital