Study to Determine if Hyperbaric Oxygen Therapy is Helpful for Treating Radiation Tissue Injuries
NCT ID: NCT00134628
Last Updated: 2016-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
248 participants
INTERVENTIONAL
2001-01-31
2015-12-31
Brief Summary
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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.)
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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A
Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy
HBO at 2.0 ATA
B
Normal Air
Sham treatment
Normal air under pressure (1.1 ATA)
Interventions
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Hyperbaric Oxygen Therapy
HBO at 2.0 ATA
Sham treatment
Normal air under pressure (1.1 ATA)
Eligibility Criteria
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Inclusion Criteria
* Hypovascularity
* Diarrhea
* Cramping
* Obstruction
* Stricture
* Pain
* Hemorrhage
* Wall Changes
* Ulceration
* Hypocellularity
* Mucosal thickening
* Vomiting
* Tenesmus
* Constipation
* Perforation
* Fistula
* Obstipation
* Tissue hypoxia
Exclusion Criteria
* 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.
ALL
No
Sponsors
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National Baromedical Services
OTHER
Responsible Party
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Dick Clarke
President, National Baromedical Research Foundation
Principal Investigators
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Dick Clarke, CHT
Role: PRINCIPAL_INVESTIGATOR
National Baromedical Services
Locations
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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)
Countries
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References
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Curi MM, Dib LL. Osteoradionecrosis of the jaws: a retrospective study of the background factors and treatment in 104 cases. J Oral Maxillofac Surg. 1997 Jun;55(6):540-4; discussion 545-6. doi: 10.1016/s0278-2391(97)90478-x.
Joseph DL, Shumrick DL. Risks of head and neck surgery in previously irradiated patients. Arch Otolaryngol. 1973 May;97(5):381-4. doi: 10.1001/archotol.1973.00780010393005. No abstract available.
Samuels L, Granick MS, Ramasastry S, Solomon MP, Hurwitz D. Reconstruction of radiation-induced chest wall lesions. Ann Plast Surg. 1993 Nov;31(5):399-405. doi: 10.1097/00000637-199311000-00003.
Hart GB, Mainous EG. The treatment of radiation necrosis with hyperbaric oxygen (OHP). Cancer. 1976 Jun;37(6):2580-5. doi: 10.1002/1097-0142(197606)37:63.0.co;2-h.
Marx RE. Osteoradionecrosis: a new concept of its pathophysiology. J Oral Maxillofac Surg. 1983 May;41(5):283-8. doi: 10.1016/0278-2391(83)90294-x.
Marx RE. A new concept in the treatment of osteoradionecrosis. J Oral Maxillofac Surg. 1983 Jun;41(6):351-7. doi: 10.1016/s0278-2391(83)80005-6. No abstract available.
Bevers RF, Bakker DJ, Kurth KH. Hyperbaric oxygen treatment for haemorrhagic radiation cystitis. Lancet. 1995 Sep 23;346(8978):803-5. doi: 10.1016/s0140-6736(95)91620-2.
Woo TC, Joseph D, Oxer H. Hyperbaric oxygen treatment for radiation proctitis. Int J Radiat Oncol Biol Phys. 1997 Jun 1;38(3):619-22. doi: 10.1016/s0360-3016(97)00017-5.
Williams JA Jr, Clarke D, Dennis WA, Dennis EJ 3rd, Smith ST. The treatment of pelvic soft tissue radiation necrosis with hyperbaric oxygen. Am J Obstet Gynecol. 1992 Aug;167(2):412-5; discussion 415-6. doi: 10.1016/s0002-9378(11)91421-5.
Feldmeier JJ, Heimbach RD, Davolt DA, Brakora MJ. Hyperbaric oxygen as an adjunctive treatment for severe laryngeal necrosis: a report of nine consecutive cases. Undersea Hyperb Med. 1993 Dec;20(4):329-35.
Other Identifiers
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ISRCTN85456814
Identifier Type: -
Identifier Source: secondary_id
Project HORTIS
Identifier Type: -
Identifier Source: org_study_id
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