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 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 therapy to prophylax against late radiation tissue injury.

Condition	Intervention	Phase
Radiation Injuries Prophylaxis	Procedure: Hyperbaric Oxygen Therapy (procedure)	Phase III

Further Study Details: 

Primary Outcomes: 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.
Secondary Outcomes: 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
Expected Total Enrollment:  500

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.

Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00134628

Dick Clarke, CHT      803-434-7101    dick.clarke@palmettohealth.org
Samir Desai, MHA      803-434-7101    samir.desai@palmettohealth.org

South Carolina
      Palmetto Health Richland, Columbia,  South Carolina,  29203,  United States; Recruiting
Australia, Queensland
      Wesley Medical Center, Brisbane,  Queensland,  4064,  Australia; Recruiting
Australia, Tasmania
      Royal Hobart Hospital, Hobart,  Tasmania,  7001,  Australia; Recruiting
Mexico
      Instituto Nacional De Cancerologica, Mexico City,  14080,  Mexico; Recruiting
South Africa
      University of Pretoria Medical Center, Pretoria,  0001,  South Africa; Recruiting
Turkey
      Istanbul University Medical Center, Istanbul,  34390,  Turkey; Recruiting

Study chairs or principal investigators

Dick Clarke, CHT,  Principal Investigator,  Baromedical Research Foundation   

Study ID Numbers:  ISRCTN85456814
Last Updated:  August 24, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00134628
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30