Recurrent Laryngeal Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma
This phase II clinical trial studies how well soy isoflavones work in preventing head and neck cancer in patients with stage I-IV head and neck cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of soy isoflavones may prevent head and neck cancer recurrence.
PRIMARY OBJECTIVES:
I. To determine if short term, preoperative (300 mg/day x 14 treatment days) soy isoflavone
supplementation modulates p16 methylation (% CpG sites methylated) and expression of p16,
cyclooxygenase 2 [COX-2], vascular endothelial growth factor receptor [VEGF], epidermal
growth factor receptor [EGFR], interleukin-6 [IL6], p53 and B-cell lymphoma-extra large
[Bcl-xL] in tumor and non-tumor adjacent mucosa of patients with head and neck squamous
carcinoma undergoing curative tumor resection.
II. To estimate correlations of tumor p16 methylation (% CpG sites methylated) with
expression of p16 and levels of, IL6, VEGF, and 15-F2t-isoprostane in serum and saliva.
SECONDARY OBJECTIVES:
I. Describe the toxicity of short-term, preoperative treatment with soy isoflavone.
II. To determine overall and relapse-free survival.
OUTLINE:
Patients receive soy isoflavones orally (PO) for approximately 14 days before undergoing
surgery.
After completion of treatment, patients are followed up, within the routine cancer
management schedule, at 3, 6, 12, and 24 months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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