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

Cancer of Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075112
• Other study ID #: IRB00065591
• Secondary ID: RAD2412-13
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Est. completion date: September 2019

Study information

• Verified date: December 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

Intervention

Drug:
• Soy isoflavone
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.

Radiation:
• Radiation
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.

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

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Emory University Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Radiation Therapy Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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