This trial is active, not recruiting.

Condition cancer of head and neck
Treatments soy isoflavone, radiation, cisplatin
Phase phase 1
Sponsor Emory University
Collaborator Radiation Therapy Oncology Group
Start date November 2013
End date July 2017
Trial size 24 participants
Trial identifier NCT02075112, IRB00065591, RAD2412-13


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Study treatment: Soy isoflavone in combination with radiation therapy & cisplatin
soy isoflavone Genistein
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.
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 Platinol
Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.

Primary Outcomes

Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment
time frame: 1 year after treatment completion

Secondary Outcomes

Exploratory biomarker studies: changes in interleukin 6
time frame: 3 and 6 months post-treatment
Exploratory biomarker studies: changes in vascular endothelial growth factor
time frame: 3 and 6 months post-treatment
Exploratory biomarker studies: changes in isoprostanes levels
time frame: 3 and 6 months post-treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Kristin Higgins, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Emory University.
Location data was received from the National Cancer Institute and was last updated in October 2016.