TerminatedPhase 3

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

Stopped: Discontinued cystitis study due to poor recruitment. To continue the trial under these circumstances is considered non-viable.

United States, Australia, Mexico248 participantsStarted 2001-01

Plain-language 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.)

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

SOMA (Subjective, Objective, Management, Analytic) scale used to determine late effects to normal tissue (LENT) score

Timeframe: pre-treatment, post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years

Trial details

NCT IDNCT00134628

SponsorNational Baromedical Services

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08

View on ClinicalTrials.gov More Radiation Injuries trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.