This study is designed to answer the question "Does the addition of hyperbaric oxygen to radiation and chemotherapy improve outcomes in locally advanced head and neck squamous cell carcinomas?"
There is reason to believe that provision of hyperbaric oxygenation immediately (within 15 minutes) prior to radiation therapy will improve radiation's effect on tumor cells, particularly those that reside in a low oxygen environment.This concept has been proven in implanted tumor-bearing animals. Several small case series suggest there is a modest extension of survival in malignant gliomas.
Squamous cell carcinomas are particularly suited to hyperbaric sensitization as they have a relatively large number of hypoxic cells.
Patients concurrently receiving chemo-radiation standard of care will be placed into a hyperbaric chamber and randomized to receive either pressurized oxygen (the experimental group) or pressurized air (the sham control group).This process will be repeated prior to each scheduled radiation treatment.
Primary outcomes to be assessed are progression-free survival and disease-free survival at two years.
Several other institutions with join in this research initiative, both in the US and internationally.