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the effect of multivitamin and mineral complex on natural killer cell activity in surgically resected lung cancer patients

Not Applicable
Completed
Conditions
Neoplasms
Registration Number
KCT0005100
Lead Sponsor
Kyung Hee University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
66
Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
K cell activity;Immune cell counts (T cell, B cell, etc.);cytokines(IL-6,-10, TGF-beta)
Secondary Outcome Measures
NameTimeMethod
Quality of Life;side effect related to the investigational food
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