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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Head and Neck
• Intervention / Treatment: Drug: Soy isoflavone; Radiation: Radiation; Drug: Cisplatin

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • Emory University Winship Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Soy isoflavone; Study treatment: Soy isoflavone in combination with radiation therapy & cisplatin

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.; Other Names: Genistein; 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.; Other Names: Platinol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Radiation Therapy Oncology Group

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Soy; Cisplatin; Radiation Therapy; Isoflavone
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Estrogens, Non-Steroidal; Estrogens; Protein Kinase Inhibitors; Anticarcinogenic Agents; Phytoestrogens; Cisplatin; Genistein
• Other Study ID Numbers: IRB00065591; RAD2412-13 (Other Identifier: Winship Cancer Institute)