This study is called a registry study. A registry study collects information about a group of people who have the same medical condition. This is not a treatment study. The type of prostate cancer treatment subjects received will be determined by the subject and their physician and will not be affected by their participation in this study. This research is being done is to create a comprehensive nationally-representative clinical database to facilitate the study of existing and emerging technologies for prostate cancer ablation. Ablation refers to the use of various energy sources to destroy both normal and cancerous prostate cells.
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.