Status:
TERMINATED
Study to Determine if Hyperbaric Oxygen Therapy is Helpful for Treating Radiation Tissue Injuries
Lead Sponsor:
National Baromedical Services
Conditions:
Radiation Injuries
Eligibility:
All Genders
Phase:
PHASE3
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 ei...
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...
Eligibility Criteria
Inclusion
- Endarteritis
- Hypovascularity
- Diarrhea
- Cramping
- Obstruction
- Stricture
- Pain
- Hemorrhage
- Wall Changes
- Ulceration
- Hypocellularity
- Mucosal thickening
- Vomiting
- Tenesmus
- Constipation
- Perforation
- Fistula
- Obstipation
- Tissue hypoxia
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00134628
Start Date
January 1 2001
End Date
December 1 2015
Last Update
January 12 2016
Active Locations (7)
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1
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
2
Wesley Medical Center
Brisbane, Queensland, Australia, 4064
3
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7001
4
Instituto Nacional de Cancerologica
Mexico City, Mexico, 14080