TCTR20231018001已完成1 期
Oral administration of oligo fucoidan improves the survival rate, quality of life, and immunity in patients with lung cancer
Department of Nutrition, Hungkuang University0 个研究点目标入组 20 人开始时间: 2023年10月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
In this study, the survival rate of the fucoidan group (28.6%) was higher than that of the control group (20.0%). In terms of overall quality of life, an increase was noted in the fucoidan group during the study period; the overall quality was improved than that of the control group. Oilgo-fucoidan increases the population of CD19 lymphocytes. neutrophil-to-lymphocyte ratio (NLR) seemed to be lower in the fucoidan group than in the control group.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 80 Years（—）
- 性别
- All
入选标准
- •(1) Male or female subjects must be aged between 20 and 80 years at the time of screening
- •(2) The estimated remaining lifespan should exceed 12 weeks, as per the assessment of the test subject
- •(1) Male or female subjects must be aged between 20 and 80 years at the time of screening
- •(2) The estimated remaining lifespan should exceed 12 weeks, as per the assessment of the test subject.
- •(3) Subjects must be diagnosed with lung cancer based on cytology or histology
- •(4) During the screening process, the subjects must meet the criteria of being in-eligible for surgical resection of lung cancer and have a disease stage beyond or higher than IIIB
- •(5) In order to meet the requirements of the Response Evaluation Criteria (RECIST version 1.1), the subject must have at least one measurable tumor lesion
- •(6) The physical condition of the subject must be assessed using
- •ECOG score, which should be between 0-2
- •(7) Subjects must be able to consume drugs orally
- •(8) Subjects must meet the following appropriate bone marrow, kidney and liver functions: (a) Absolute neutrophil count (ANC): 1,500/mm3 (b) Platelets: 100,000/mm3; (c) Haemoglobin: 9.0 g/dL. (d) Renal function: Serum creatinine (Cre) levels should be within the normal range. (f) Liver function: aspartate aminotrans-ferase (AST) and alanine aminotransferase (ALT) values should be 2.5-fold higher than the upper limit of normal values. Else, the AST and ALT levels should be < 5 times the upper limit value and bilirubin levels should be 1.5 times the upper limit of normal value
- •(9) The subject must be able to understand the experiment and be willing to follow the instructions of the trial plan and sign the consent form.
排除标准
- •The exclusion criteria are listed as follows 1) Grade 2 peripheral neuropathy; (2) Epileptic seizures in the 12 months preceding trial enrolment; (3) Recent use of herbal medicine, over-the-counter anti-cancer supplements, or approved Chinese medicine for tumour treatment within 2 weeks prior to random assignment; (4) Presence of significant uncon-trolled clinical symptoms including but not limited to unmanaged nausea, vomiting, diarrhoea, progressive infection, congestive heart failure, unstable angina, arrhythmia, mental illness impacting compliance, history of severe haem-optysis, or any other medical condition posing elevated risk or toxicity, as determined by the moderator; (5) Pregnancy or breastfeeding; (6) Participation in other drug-related clinical trials within 30 days before the screening period.
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