Clinical Trial: Study to Determine if Hyperbaric Oxygen Therapy is Helpful for Treating Radiation Tissue Injuries

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Hyperbaric Oxygen Radiation Tissue Injury Study - Project HORTIS

Brief Summary:

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.)


Detailed Summary:

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
Sponsor: Baromedical Research Foundation

Current Primary Outcome: 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 ]

Original Primary Outcome: SOMA (Subjective, Objective, Management, Analytic) scale used to determine LENT score pre-treatment, post-treatment (HBO and placebo) and at follow ups at 3 month, 6 month, 1 year thru 5 years.

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Clinical assessment using one of the following criteria:
  • a) Healed
  • b) Significantly improved (> 50% lesion resolution)
  • c) Modestly improved (< 50% lesion resolution)
  • d) Not improved
  • e) Other (e.gg lesion recurrence, lesion size progression)
  • done post-treatment (HBO and placebo) and at follow ups at 3 month, 6 month, 1 year thru 5 years


Information By: Baromedical Research Foundation

Dates:
Date Received: August 23, 2005
Date Started: January 2001
Date Completion:
Last Updated: January 11, 2016
Last Verified: February 2012