Clinical trial NCT02007200
Conditions: 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
Sponsor: National Cancer Institute (NCI)
Start date: 2009-07-01; Completion date: 2015-09-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Soy Isoflavones intervention 3: Survey Administration
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO intervention 3: Ancillary studies

Protocol documents: