Symptoms and General Pathology

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Rare Diseases

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Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Carcinoma, Verrucous

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Oral Squamous Cell Carcinoma

Tongue Cancer

Herbal and Botanical

All Drugs and Chemicals

Soy Bean

Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.

Laboratory Biomarker Analysis

Soy Isoflavones

Survey Administration

Greg Wolf

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.

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

The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.

Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.

Overall survival at last follow-up will be determined.

Relapse-free survival will be determined at the last follow-up visit.

National Cancer Institute (NCI)

55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.

Treatment (Soy Isoflavones)

Age, Continuous

Sex: Female, Male

55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.

Gregory T. Wolf, M.D.

Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone

We are seeking additional funding to hire the personnel to perform the serum/saliva markers. Until further notice markers will be unable to be analyzed.

Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF

The Number of Participants Alive at Follow-up

The Number of Participants Alive Without Relapse at Last Follow-up

Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.

55 patients were enrolled. 3 of these patients did not receive treatment.

Spots Global Cancer Trial Database for stage i laryngeal verrucous carcinoma