Overview

This trial is active, not recruiting.

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
Treatments laboratory biomarker analysis, soy isoflavones, survey administration
Phase phase 2
Sponsor National Cancer Institute (NCI)
Start date July 2009
End date September 2015
Trial size 44 participants
Trial identifier NCT02007200, NCI-2011-03618, NCT01028001, P30CA046592, UMCC 2009.008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
laboratory biomarker analysis
Correlative studies
soy isoflavones NovaSoy
Given PO
survey administration
Ancillary studies

Primary Outcomes

Measure
Change in p16 methylation (% CpG sites methylated) and expression of p16, COX-2, VEGF, EGFR, IL6, p53 and BclxL in tumor and non-tumor adjacent mucosa
time frame: From baseline to surgery
Correlations of tumor p16 methylation status with serum/saliva markers of p16, IL6, and VEGF
time frame: Up to 12 months

Secondary Outcomes

Measure
Incidence of observed toxicities
time frame: Up to 30 days after surgery
Overall survival
time frame: Up to 24 months
Relapse-free survival
time frame: Up to 24 months

Eligibility Criteria

Male or female participants from 19 years up to 79 years old.

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

Additional Information

Official title A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma
Principal investigator Greg Wolf
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).