Proctitis IV B

A component study to HORTIS IV is presently under development. Its goal is to compare the effectiveness of different hyperbaric treatment pressures. Therapeutic dosing of late radiation tissue injury is not based upon a precise dose of hyperbaric oxygenation for the pathophysiological process. Rather, it is based upon avoidance of oxygen toxicity.

There are several good reasons to address this dosing issue. Increasing the hyperbaric treatment pressure has been demonstrated to increase vascular density (Marx RE et al. Relationship Of Oxygen Dose To Angiogenesis Induction In Irradiated Tissue. The American Journal of Surgery. Vol. 160 p 519 – 524 November 1990). This process has not however been evaluated critically. Higher pressures increase the risk of oxygen toxicity in the patient. They also increase the risk and incidence of decompression sickness in staff members who accompany patients within "multiplace" hyperbaric delivery systems.

HORTIS IV B will not involve a placebo arm. It is anticipated that this will eliminate a barrier to facility enrollment where the treatment of radiation proctitis is essentially a standard of care.

For further information regarding HORTIS IV B, please contact us.