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

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.

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.

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