Tocotrienol as a nutritional supplement in patients with advanced pulmonal cancer

Vejle Hospital0 个研究点目标入组 190 人开始时间: 2015年10月16日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Histologically confirmed non-small cell lung cancer, including squamous cell carcinomas, adenocarcinomas and non-neuroendocrine large cell carcinomas
•Patients with advanced stages of NSCLC who are candidates to first-line platinum-based doublet chemotherapy
•Measurable disease by RECIST 1.1
•Age = 18 years.
•Performance status 0-2.
•Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
•- WBC = 3.0 * 10^9/l or neutrophils (ANC) = 1.5 * 10^9/l
•- Platelet count = 100 * 10^9/l
•- Hemoglobin = 6 mmol/l
•- Serum bilirubin < 2.0 * ULN
•- Serum transaminase = 2.5 * ULN
•- Serum creatinine = 1.5 ULN
•Written and orally informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 76
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 114

•Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
•Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
•Patients who have received prior chemotherapy for NSCLC
•Patients with NSCLC who are candidates to neoadjuvant chemotherapy or curative chemoradiotherapy
•Underlying disease not adequately treated (diabetes, cardiac disease)
•Allergy to the active substance or any of the auxiliary agents
•Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
•Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.

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