Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck

Phase 1CompletedNCT02075112

Emory University24 enrolled

Overview

The purpose of this study is to determine if soy supplementation during chemotherapy and radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a side effect of the standard treatment, and we are testing whether soy supplementation during treatment may reduce this symptom and other side effects of chemoradiation.

Concurrent chemoradiation is the standard of care for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Improving the outcome for patients with this disease remains a major challenge.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer of Head and Neck

Interventions

Soy isoflavoneDRUG

Patients will receive genistein 150 mg daily for the duration of radiation treatment. If a patient is experiencing significant side effects attributable to genistein, the treating physician has the option to reduce genistein to 150 mg every other day.

RadiationRADIATION

All patients will undergo computed tomography (CT) simulation with intravenous (IV) contrast unless medical contraindications to IV contrast exist. Gross disease will be treated to 70 Gy in 2 Gy/day.

CisplatinDRUG

Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Biopsy proven squamous cell carcinoma of the head and neck (SCCHN) * Primary disease site involving the oropharynx * Clinical stage III or IV * Age ≥ 18 * Karnofsky Performance Status (KPS) ≥ 70 * Adequate bone marrow, kidney, and hepatic function (no laboratory value \> 2 times the normal limit) * Amylase (0-160 U/L) and lipase (0-130 U/L) levels within 1.5 times the range of normal Exclusion Criteria: * Prior history of SCCHN * Prior history of radiation to the head and neck region * KPS \< 70 * Soy allergy * Contraindication to cisplatin chemotherapy or plans to alter or reduce cisplatin therapy * Any head and neck cancer of non-squamous histology * Any head and neck subsite other than oropharynx (including unknown primary site) * Patients who are pregnant or lactating * Patients who may benefit from surgical resection

Locations (2)

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment

The primary outcome of this study is the percentage of patients with symptomatic (grade 2 or higher) xerostomia at 1 year post-treatment, assessed by the Late Effects of Normal Tissues (LENT)/Subjective, Objective, Management, Analytic (SOMA) method.

Time frame: 1 year after treatment completion

Secondary Outcomes

Exploratory biomarker studies: changes in interleukin 6

Serum baseline levels of interleukin 6 (IL6) and their levels at 3 and 6 months post-treatment.

Time frame: 3 and 6 months post-treatment

Exploratory biomarker studies: changes in vascular endothelial growth factor

Serum baseline levels of vascular endothelial growth factor (VEGF) and their levels at 3 and 6 months post-treatment.

Time frame: 3 and 6 months post-treatment

Exploratory biomarker studies: changes in isoprostanes levels

Baseline urinary levels of isoprostanes before treatment, and 3 and 6 months post-treatment, as a potential marker of oxidative stress associated with chemoradiation.

Time frame: 3 and 6 months post-treatment

Data from ClinicalTrials.gov

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