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

This study has been terminated.
(Discontinued cystitis study due to poor recruitment. To continue the trial under these circumstances is considered non-viable.)
Sponsor:
Information provided by (Responsible Party):
Dick Clarke, Baromedical Research Foundation
ClinicalTrials.gov Identifier:
NCT00134628
First received: August 23, 2005
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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.)


Condition Intervention Phase
Radiation Injuries
Procedure: Hyperbaric Oxygen Therapy
Procedure: Sham treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Radiation Tissue Injury Study - Project HORTIS

Resource links provided by NLM:


Further study details as provided by Baromedical Research Foundation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Healed [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Not improved [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 248
Study Start Date: January 2001
Estimated Study Completion Date: December 2015
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Hyperbaric Oxygen Therapy
Procedure: Hyperbaric Oxygen Therapy
HBO at 2.0 ATA
Sham Comparator: B
Normal Air
Procedure: Sham treatment
Normal air under pressure (1.1 ATA)

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Endarteritis
  • Hypovascularity
  • Diarrhea
  • Cramping
  • Obstruction
  • Stricture
  • Pain
  • Hemorrhage
  • Wall Changes
  • Ulceration
  • Hypocellularity
  • Mucosal thickening
  • Vomiting
  • Tenesmus
  • Constipation
  • Perforation
  • Fistula
  • Obstipation
  • Tissue hypoxia

Exclusion Criteria:

  • Pregnancy
  • Reactive airway disease
  • Radiographic evidence of pulmonary blebs or bullae
  • Untreated pneumothorax
  • Previously documented ejection fraction less than 35%
  • History of seizures except childhood febrile seizures
  • Cardiovascular instability
  • Mechanical ventilator support with the exception of those patients who are immediately (1-5 days) post-operative
  • Unable to follow simple commands
  • Not orientated to person, place, time
  • Participating as a subject in any other medical or biomedical research project; if previously involved as a subject, sufficient time must have elapsed to permit "wash out" of any investigational agent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134628

Locations
United States, South Carolina
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
Australia, Queensland
Wesley Medical Center
Brisbane, Queensland, Australia, 4064
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7001
Mexico
Instituto Nacional de Cancerologica
Mexico City, Mexico, 14080
South Africa
University of Stellenbosch
Cape Town, South Africa
University of Pretoria Medical Center
Pretoria, South Africa, 0001
Turkey
Istanbul University Medical Center
Istanbul, Turkey, 34390
Sponsors and Collaborators
Baromedical Research Foundation
Investigators
Principal Investigator: Dick Clarke, CHT Baromedical Research Foundation
  More Information

Additional Information:
Publications:

Responsible Party: Dick Clarke, President, National Baromedical Research Foundation, Baromedical Research Foundation
ClinicalTrials.gov Identifier: NCT00134628     History of Changes
Other Study ID Numbers: Project HORTIS, ISRCTN85456814
Study First Received: August 23, 2005
Last Updated: February 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baromedical Research Foundation:
Hyperbaric Oxygenation
Radiation injuries
Prophylaxis
Proctitis
Cystitis
Enteritis
Osteoradionecrosis

Additional relevant MeSH terms:
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014