A Phase II Study of IZN-6N4 to Reduce Mouth Sores in Patients with Head and Neck Cancer Receiving Chemotherapy and Radiation Therapy

Protocol
12-204
Full Title
Phase II Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients with Head and Neck Cancer
Phase
II
Purpose

Chemotherapy and radiation therapy are commonly given to treat patients with head and neck cancers, but these treatments can cause painful and uncomfortable mouth sores (oral mucositis). The purpose of this study is to see if an investigational mouthwash called IZN-6N4 can prevent or lessen the effects of mouth sores in these patients.

IZN-6N4 is a mixture of three plant extracts known to reduce swelling and to help protect the lining of the mouth. Patients in this study will be randomly assigned to receive the IZN-6N4 mouthwash or a placebo (inactive) mouthwash.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have head and neck cancer that will be treated with 3D conformal or intensity-modulated radiation therapy as well as chemotherapy.
  • Patients should be able to eat soft solid foods and to rinse with a mouthwash.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Nancy Lee at 212-639-3341.

Disease(s)
Head & Neck Cancer
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