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

Phase 1

Completed

• Conditions: Cancer of Head and Neck
• Interventions: Drug: Soy isoflavone; Radiation: Radiation; Drug: Cisplatin

• Registration Number: NCT02075112
• Lead Sponsor: Emory University

Brief Summary

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

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-03-03
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Soy isoflavone	Radiation	Study treatment: Soy isoflavone in combination with radiation therapy \& cisplatin
Soy isoflavone	Cisplatin	Study treatment: Soy isoflavone in combination with radiation therapy \& cisplatin
Soy isoflavone	Soy isoflavone	Study treatment: Soy isoflavone in combination with radiation therapy \& cisplatin

Primary Outcome Measures

Name	Time	Method
Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment	1 year after treatment completion	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.

Secondary Outcome Measures

Name	Time	Method
Exploratory biomarker studies: changes in interleukin 6	3 and 6 months post-treatment	Serum baseline levels of interleukin 6 (IL6) and their levels at 3 and 6 months post-treatment.
Exploratory biomarker studies: changes in vascular endothelial growth factor	3 and 6 months post-treatment	Serum baseline levels of vascular endothelial growth factor (VEGF) and their levels at 3 and 6 months post-treatment.
Exploratory biomarker studies: changes in isoprostanes levels	3 and 6 months post-treatment	Baseline urinary levels of isoprostanes before treatment, and 3 and 6 months post-treatment, as a potential marker of oxidative stress associated with chemoradiation.

Trial Locations

Locations (2)

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Emory University Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States