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

Completed · Phase 1

Conditions studied: Cancer of Head and Neck

In brief

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.

Key facts

Study ID

NCT02075112

Run by

Emory University

People needed

24

Starts

2013-11-01

Expected to finish

2019-09-01

Last updated by the study team

2019-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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