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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Radiation Injuries

In brief

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.)

Key facts

Study ID

NCT00134628

Run by

National Baromedical Services

People needed

248

Starts

2001-01-01

Expected to finish

2015-12-01

Last updated by the study team

2016-01-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Palmetto Health Richland — Columbia, South Carolina, United States
• Wesley Medical Center — Brisbane, Queensland, Australia
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• Instituto Nacional de Cancerologica — Mexico City, Mexico
• University of Stellenbosch — Cape Town, South Africa
• University of Pretoria Medical Center — Pretoria, South Africa
• Istanbul University Medical Center — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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