NCT02075112

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of Head and Neck

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-11-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2014-03-03
• Last updated: 2019-12-06

Locations

2 sites across 1 country: United States