A Phase 3 interventional study of Hyperbaric Oxygen Therapy and Sham treatment in Radiation Injuries, sponsored by National Baromedical Services. Terminated at 7 sites in 5 countries. Per ClinicalTrials.gov, last updated 2016-01-12.
Sponsored by National Baromedical Services · Phase 3, Interventional, and Treatment
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 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.
116 studies on the registry are indexed under Radiation Injuries; 50 are open to participants now.
This study's enrollment of 248 is above the median of 68 across 70 interventional studies indexed under Radiation Injuries.
Browse Radiation Injuries studies →National Baromedical Services is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Hyperbaric Oxygen Therapy
Procedure: Hyperbaric Oxygen Therapy
Normal Air
Procedure: Sham treatment
HBO at 2.0 ATA
Normal air under pressure (1.1 ATA)
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
The record gives a start of Jan 2001, a primary completion of Aug 2011 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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National Baromedical Services