Skip to main content
OpenTrials
Completed

NCT Number: NCT02075112

Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer of Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Emory University Hospital Midtown, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soy isoflavone

Drug

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.

Cisplatin

Drug

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

Other names: Platinol

Primary outcomes

  1. Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment

    Time frame: 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 outcomes

  1. Exploratory biomarker studies: changes in interleukin 6

    Time frame: 3 and 6 months post-treatment

    Serum baseline levels of interleukin 6 (IL6) and their levels at 3 and 6 months post-treatment.

  2. Exploratory biomarker studies: changes in vascular endothelial growth factor

    Time frame: 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.

  3. Exploratory biomarker studies: changes in isoprostanes levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Radiation Therapy Oncology Group

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2014
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.