Hyperbaric Oxygen Radiation Tissue Injury Study – Project HORTIS
Description:
Radiation therapy is a key component of the control and eradication of malignant disease.
Adequate tumoricidal doses may, however, result in damage to surrounding healthy tissue.
Therapeutic radiation injuries to non-target tissues can be divided into acute, sub-acute,
and delayed complications. Acute injuries are considered a direct cellular toxicity,
self-limiting, and in most cases successfully managed symptomatically. Sub-acute injuries are
typically identifiable in only a few organ systems, e.g., radiation pneumonitis. These, too,
are generally limited but occasionally evolve to late complications. Late changes occur
several months to many years after completing radiotherapy.
The etiology of radiation’s late effects to normal tissue (LENT) varies somewhat between
organ systems. Its hallmark, however, is one of culminating in an obliterative endarteritis,
and local hypoxia.
The incidence of LENT is related to both total radiation exposure and the length of time a
patient is out from completing radiotherapy. The higher the dose, the longer the interval
from exposure, the greater the risk. In many cases, resulting radionecrotic lesions seriously
impair form and function, and require extensive surgical correction or repair. Such surgery
is fraught with complications, hence the inclusion of a "prophylactic" hyperbaric oxygen arm.
A disturbing degree of mortality further complicates the development of LENT.
Hyperbaric oxygen has been utilized in the treatment of radiation tissue injury for several
decades. Most of the supportive basic science and clinical evidence stems from the management
of mandibular osteoradionecrosis. More recently, the use of hyperbaric oxygen has been
extended to other anatomic sites. This expanded use is based, in large part, on a presumed
common underlying pathophysiology of LENT, regardless of its anatomic location. Supportive
clinical evidence for these other sites is limited, however, and in need of a greater degree
of scientific scrutiny.
Condition:
Radiation Injuries
Treatment:
Hyperbaric Oxygen Therapy
Start Date:
January 2001
Sponsor:
National Baromedical Services
For More Information:
https://clinicaltrials.gov/show/NCT00134628