A Randomized, Double-blind Study to Evaluate the Clinical Effect and Safety of Fucoidan in Patients With Squamous Cell Carcinomas of the Head and Neck
This phase II study is a randomized, double-blind study that seeks to evaluate the clinical effects and safety of fucoidan in the treatment of cancer patients with stage III/IV head and neck squamous cell carcinoma. Patients will be centrally randomized in a 1:1 ratio to receive either Fucoidan or placebo (potato starch) Eligible subjects will receive fucoidan twice daily (BID) in combination with chemotherapy and radiation therapy over a 24-week treatment period. Clinical effects and safety parameters for all subjects who complete the treatment period will be followed for an additional 72 weeks after the treatment period.
• The patients with stage III/IV head and neck squamous cell carcinoma (HNSCC) withoutdistant metastasis who had not received any treatment to head and neck cancer can be enrolled in this study.
• Completed a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the head and neck (including the primary tumor and neck nodes) within 6 weeks prior to enrollment.
• Adequate renal function, with serum creatinine ≤ 1.5 mg/dL. Patients with serum creatinine \> 1.5 mg/dL may be eligible if calculated creatinine clearance ≥ 55 mL/min as based on the results of the Cockcroft-Gault Equation or 24-hour urine collection.
• Age ≥ 20 years and ≤ 75 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.
• Expected lifespan \> 6 months.
• Adequate bone marrow function, as defined by absolute neutrophil count ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL.
• Adequate hepatic function, with total bilirubin ≤ 1.5 × upper normal limit (UNL; patients with hyperbilirubinemia caused by Gilbert's syndrome may be eligible if total bilirubin ≤ 2.5 × UNL), aspartate aminotransferase (AST) ≤ 2.5 × UNL, alanine aminotransferase (ALT) ≤ 2.5 × UNL, and alkaline phosphatase (ALP) ≤ 2.5 × UNL.
• Men and women of childbearing potential must consent to the use of effective contraception while on treatment period.
⁃ Patients must be able to understand and be willing to sign a written informed consent document.
⁃ Patients must be able to comply with the study protocol.