patients with NSCLC non-small cell lung cancer, oligo-fucoidan, survival rate, quality of life, immunity
Conditions
Interventions
Oligo-fucoidan use 2200 mg at a time twice a day for 48 weeks
Experimental Dietary Supplement
Sponsors
Department of Nutrition, Hungkuang University
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the survival rate at 3 months after end of the intervention unpaired t-test | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Taiwan
Contacts
Public ContactYaLing Chiou
Hungkuang University
Outcome results
None listed