Oral administration of oligo fucoidan improves the survival rate, quality of life, and immunity in patients with lung cancer
- Conditions
- patients with NSCLCnon-small cell lung cancer, oligo-fucoidan, survival rate, quality of life, immunity
- Registration Number
- TCTR20231018001
- Lead Sponsor
- Department of Nutrition, Hungkuang University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
(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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the survival rate at 3 months after end of the intervention unpaired t-test
- Secondary Outcome Measures
Name Time Method quality of life at 3 months after end of the intervention unpaired t-test,immunity at 3 months after end of the intervention unpaired t-test