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

Primary Purpose

Cancer of Head and Neck

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Soy isoflavone
Radiation
Cisplatin
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Head and Neck focused on measuring Soy, Isoflavone, Radiation Therapy, Cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University Hospital Midtown
  • Emory University Winship Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Soy isoflavone

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Exploratory biomarker studies: changes in interleukin 6
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
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
Baseline urinary levels of isoprostanes before treatment, and 3 and 6 months post-treatment, as a potential marker of oxidative stress associated with chemoradiation.

Full Information

First Posted
February 12, 2014
Last Updated
December 5, 2019
Sponsor
Emory University
Collaborators
Radiation Therapy Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02075112
Brief Title
Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Radiation Therapy Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Head and Neck
Keywords
Soy, Isoflavone, Radiation Therapy, Cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soy isoflavone
Arm Type
Experimental
Arm Description
Study treatment: Soy isoflavone in combination with radiation therapy & cisplatin
Intervention Type
Drug
Intervention Name(s)
Soy isoflavone
Other Intervention Name(s)
Genistein
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Description
Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.
Primary Outcome Measure Information:
Title
Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment
Description
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 Outcome Measure Information:
Title
Exploratory biomarker studies: changes in interleukin 6
Description
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
Title
Exploratory biomarker studies: changes in vascular endothelial growth factor
Description
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
Title
Exploratory biomarker studies: changes in isoprostanes levels
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Higgins, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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