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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Stage I Laryngeal Squamous Cell Carcinoma; Stage II Lip and Oral Cavity Squamous Cell Carcinoma; Recurrent Hypopharyngeal Squamous Cell Carcinoma; Stage III Laryngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Stage IV Hypopharyngeal Squamous Cell Carcinoma; Stage I Oropharyngeal Squamous Cell Carcinoma; Stage IVA Oral Cavity Verrucous Carcinoma; Stage I Lip and Oral Cavity Squamous Cell Carcinoma; Tongue Carcinoma; Stage IVA Oropharyngeal Squamous Cell Carcinoma; Recurrent Lip and Oral Cavity Squamous Cell Carcinoma; Stage II Oropharyngeal Squamous Cell Carcinoma; Stage III Oral Cavity Verrucous Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Stage II Oral Cavity Verrucous Carcinoma; Stage IVA Laryngeal Squamous Cell Carcinoma; Stage II Laryngeal Verrucous Carcinoma; Stage III Lip and Oral Cavity Squamous Cell Carcinoma; Stage III Laryngeal Verrucous Carcinoma; Stage III Oropharyngeal Squamous Cell Carcinoma; Stage III Hypopharyngeal Squamous Cell Carcinoma; Stage II Hypopharyngeal Squamous Cell Carcinoma; Stage I Laryngeal Verrucous Carcinoma; Stage IVA Laryngeal Verrucous Carcinoma; Stage II Laryngeal Squamous Cell Carcinoma; Stage I Hypopharyngeal Squamous Cell Carcinoma; Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma; Recurrent Oral Cavity Verrucous Carcinoma; Recurrent Laryngeal Verrucous Carcinoma; Stage I Oral Cavity Verrucous Carcinoma

Treatments: Drug: Soy Isoflavones; Other: Laboratory Biomarker Analysis; Other: Survey Administration

Study type: Interventional

Funder types: NIH

Identifiers

NCT02007200

NCI-2011-03618 (Registry Identifier)

P30CA046592 (U.S. NIH Grant/Contract)

UMCC 2009.008 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
• Disease must be Stage I, II, III or IVa
• Tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
• Patients must give documented informed consent to participate in this study

Exclusion criteria

• Documented evidence of distant metastases
• Ongoing acute medical condition such as uncontrolled coronary artery disease, emphysema, or diabetes mellitus that would preclude surgical resection
• Pregnancy or lactation; patients of child bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of soy administration
• A medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment or comply with administration of study drug
• Patients residing in prison
• Any patient with a history of breast or ovarian cancer
• Allergy to soy products

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Treatment (soy isoflavones)

Experimental group

Description:

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

Treatment:

Other: Survey Administration

Other: Laboratory Biomarker Analysis

Drug: Soy Isoflavones