Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
There is a need for improving the effect of first-line chemotherapy for lung cancer patients, preferably by using an approach with none or very few side effects.
In this trial the investigators incorporate δ-tocotrienol/placebo as a nutritional supplement on top of standard chemotherapy for patients with advanced non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
- •White blood cells (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 * upper level of normal (ULN)
- •Serum transaminase ≤ 2.5 * ULN
- •Serum creatinine ≤ 1.5 ULN
- •Written and orally informed consent.
排除标准
- •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.
研究组 & 干预措施
Performance status 0-1, Arm A
Day 1: Cisplatin 75 mg/m2 plus vinorelbine 25 mg/m2. Day 8: Capsule vinorelbine 50 mg/m2. Tocotrienol 300 mg x 3 daily until progression.
干预措施: Tocotrienol 300 mg x 3 daily until progression (Dietary Supplement)
Performance status 0-1, Arm B
Day 1: Cisplatin 75 mg/m2 plus vinorelbine 25 mg/m2. Day 8: Capsule vinorelbine 50 mg/m2. Placebo 1 capsule x 3 daily until progression.
干预措施: Placebo 1 capsule x 3 daily until progression (Drug)
Performance status 2, Arm A
Day 1: Carboplatin area under the curve (AUC)=5 plus vinorelbine 30mg/m2. Day 8: Capsule vinorelbine 60 mg/m2. Tocotrienol 300 mg x 3 daily until progression
干预措施: Tocotrienol 300 mg x 3 daily until progression (Dietary Supplement)
Performance status 2, Arm B
Day 1: Carboplatin area under the curve (AUC)=5 plus vinorelbine 30mg/m2. Day 8: Capsule vinorelbine 60 mg/m2. Placebo 1 capsule x 3 daily until progression
干预措施: Placebo 1 capsule x 3 daily until progression (Drug)
结局指标
主要结局
Progression free survival
时间窗: From date of randomization until date of first documented progression; assessed up to 36 months
次要结局
未报告次要终点