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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00134628
Registration number
NCT00134628
Ethics application status
Date submitted
23/08/2005
Date registered
25/08/2005
Date last updated
12/01/2016
Titles & IDs
Public title
Study to Determine if Hyperbaric Oxygen Therapy is Helpful for Treating Radiation Tissue Injuries
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Scientific title
Hyperbaric Oxygen Radiation Tissue Injury Study - Project HORTIS
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Secondary ID [1]
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ISRCTN85456814
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Secondary ID [2]
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Project HORTIS
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Radiation Injuries
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Condition category
Condition code
Skin
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Other skin conditions
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Injuries and Accidents
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Other injuries and accidents
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Injuries and Accidents
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Poisoning
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Injuries and Accidents
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0
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Burns
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Hyperbaric Oxygen Therapy
Treatment: Surgery - Sham treatment
Active Comparator: A - Hyperbaric Oxygen Therapy
Sham Comparator: B - Normal Air
Treatment: Surgery: Hyperbaric Oxygen Therapy
HBO at 2.0 ATA
Treatment: Surgery: Sham treatment
Normal air under pressure (1.1 ATA)
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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SOMA (Subjective, Objective, Management, Analytic) scale used to determine late effects to normal tissue (LENT) score
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Assessment method [1]
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Timepoint [1]
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pre-treatment, post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
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Secondary outcome [1]
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Clinical assessment using one of the following criteria:
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Assessment method [1]
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Timepoint [1]
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post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
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Secondary outcome [2]
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Healed
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Assessment method [2]
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Timepoint [2]
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post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
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Secondary outcome [3]
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Modestly improved (< 50% lesion resolution)
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Assessment method [3]
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Timepoint [3]
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post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
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Secondary outcome [4]
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Not improved
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Assessment method [4]
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Timepoint [4]
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post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
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Secondary outcome [5]
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Other (e.g. lesion recurrence, lesion size progression)
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Assessment method [5]
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Timepoint [5]
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post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
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Secondary outcome [6]
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Significant Improvement (>50% lesion resolution)
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Assessment method [6]
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Timepoint [6]
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post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
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Eligibility
Key inclusion criteria
- Endarteritis
- Hypovascularity
- Diarrhea
- Cramping
- Obstruction
- Stricture
- Pain
- Hemorrhage
- Wall Changes
- Ulceration
- Hypocellularity
- Mucosal thickening
- Vomiting
- Tenesmus
- Constipation
- Perforation
- Fistula
- Obstipation
- Tissue hypoxia
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2001
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
248
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Recruitment in Australia
Recruitment state(s)
QLD,TAS
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Recruitment hospital [1]
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Wesley Medical Center - Brisbane
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Recruitment hospital [2]
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Royal Hobart Hospital - Hobart
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Recruitment postcode(s) [1]
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4064 - Brisbane
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Recruitment postcode(s) [2]
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7001 - Hobart
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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South Carolina
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Country [2]
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Mexico
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State/province [2]
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Mexico City
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Country [3]
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South Africa
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State/province [3]
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Cape Town
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Country [4]
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South Africa
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State/province [4]
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Pretoria
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Country [5]
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Turkey
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State/province [5]
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Istanbul
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Funding & Sponsors
Primary sponsor type
Other
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Name
National Baromedical Services
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 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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Trial website
https://clinicaltrials.gov/ct2/show/NCT00134628
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Dick Clarke, CHT
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Address
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National Baromedical Services
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00134628
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