Clinical Trials Directory

Trials / Completed

CompletedNCT02007200

Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery

A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
55 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
19 Years – 79 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGSoy IsoflavonesGiven PO
OTHERSurvey AdministrationAncillary studies

Timeline

Start date
2009-07-01
Primary completion
2015-09-01
Completion
2015-09-01
First posted
2013-12-10
Last updated
2016-10-24
Results posted
2016-10-24

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02007200. Inclusion in this directory is not an endorsement.