Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery
Condition: Recurrent Hypopharyngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Laryngeal Verrucous Carcinoma; Recurrent Lip and Oral Cavity Squamous Cell Carcinoma; Recurrent Oral Cavity Verrucous Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Stage I Hypopharyngeal Squamous Cell Carcinoma; Stage I Laryngeal Squamous Cell Carcinoma; Stage I Laryngeal Verrucous Carcinoma; Stage I Lip and Oral Cavity Squamous Cell Carcinoma; Stage I Oral Cavity Verrucous Carcinoma; Stage I Oropharyngeal Squamous Cell Carcinoma; Stage II Hypopharyngeal Squamous Cell Carcinoma; Stage II Laryngeal Squamous Cell Carcinoma; Stage II Laryngeal Verrucous Carcinoma; Stage II Lip and Oral Cavity Squamous Cell Carcinoma; Stage II Oral Cavity Verrucous Carcinoma; Stage II Oropharyngeal Squamous Cell Carcinoma; Stage III Hypopharyngeal Squamous Cell Carcinoma; Stage III Laryngeal Squamous Cell Carcinoma; Stage III Laryngeal Verrucous Carcinoma; Stage III Lip and Oral Cavity Squamous Cell Carcinoma; Stage III Oral Cavity Verrucous Carcinoma; Stage III Oropharyngeal Squamous Cell Carcinoma; Stage IV Hypopharyngeal Squamous Cell Carcinoma; Stage IVA Laryngeal Squamous Cell Carcinoma; Stage IVA Laryngeal Verrucous Carcinoma; Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma; Stage IVA Oral Cavity Verrucous Carcinoma; Stage IVA Oropharyngeal Squamous Cell Carcinoma; Tongue Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Verrucous; Squamous Cell Carcinoma of Head and Neck; Recurrence
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Laboratory Biomarker Analysis; Soy Isoflavones; Survey Administration
Intervention type(s): Other; Drug; Other
Intervention description(s): Correlative studies; Given PO; Ancillary studies
Other intervention name(s): NovaSoy; Solgen 40; Soy Isoflavone; Soybean Isoflavone Mixture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment