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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Soy Isoflavone, Genistein, in Combination With Radiation Therapy and Cisplatin in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Conditions
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Cancer of Head and Neck

Intervention / Treatment
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* Drug: Soy isoflavone
* Radiation: Radiation
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soy isoflavone<br>Study treatment: Soy isoflavone in combination with radiation therapy & cisplatin | Drug: Soy isoflavone<br>* 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.<br>* Other names: Genistein;Radiation: Radiation<br>* 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.<br>Drug: Cisplatin<br>* Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.<br>* Other names: Platinol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory biomarker studies: changes in interleukin 6 | Serum baseline levels of interleukin 6 (IL6) and their levels at 3 and 6 months post-treatment. | 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. | 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. | 3 and 6 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soy, Isoflavone, Radiation Therapy, Cisplatin