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

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Radiation Therapy Oncology Group
• Treatments: Cisplatin; Genistein

Criteria

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