Study to Determine if Hyperbaric Oxygen Therapy is Helpful for Treating Radiation Tissue Injuries
The principle objective of this research is to more precisely determine the degree of benefit that hyperbaric oxygen therapy affords in the treatment of late radiation tissue injury.
The study has eight* components. Seven involve the evaluation of established radionecrosis at varying anatomic sites (mandible, larynx, skin, bladder, rectum, colon, and gyn). The eighth will investigate the potential of hyperbaric oxygen (HBO) therapy to prophylax against late radiation tissue injury.
*(One of the arms, HORTIS IV - Proctitis has been closed to further patient recruitment. This decision was based on an interim statistical analysis which generated sufficient evidence to support closing down this arm of HORTIS.)
|Radiation Injuries||Procedure: Hyperbaric Oxygen Therapy Procedure: Sham treatment||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Hyperbaric Oxygen Radiation Tissue Injury Study - Project HORTIS|
- SOMA (Subjective, Objective, Management, Analytic) scale used to determine late effects to normal tissue (LENT) score [ Time Frame: pre-treatment, post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ]
- Clinical assessment using one of the following criteria: [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ]
- Healed [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ]
- Modestly improved (< 50% lesion resolution) [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ]
- Not improved [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ]
- Other (e.g. lesion recurrence, lesion size progression) [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ]
- Significant Improvement (>50% lesion resolution) [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ]
|Study Start Date:||January 2001|
|Study Completion Date:||December 2015|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Active Comparator: A
Hyperbaric Oxygen Therapy
Procedure: Hyperbaric Oxygen Therapy
HBO at 2.0 ATA
Sham Comparator: B
Procedure: Sham treatment
Normal air under pressure (1.1 ATA)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134628
|United States, South Carolina|
|Palmetto Health Richland|
|Columbia, South Carolina, United States, 29203|
|Wesley Medical Center|
|Brisbane, Queensland, Australia, 4064|
|Royal Hobart Hospital|
|Hobart, Tasmania, Australia, 7001|
|Instituto Nacional de Cancerologica|
|Mexico City, Mexico, 14080|
|University of Stellenbosch|
|Cape Town, South Africa|
|University of Pretoria Medical Center|
|Pretoria, South Africa, 0001|
|Istanbul University Medical Center|
|Istanbul, Turkey, 34390|
|Principal Investigator:||Dick Clarke, CHT||Baromedical Research Foundation|