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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
Scientific title
Hyperbaric Oxygen Radiation Tissue Injury Study - Project HORTIS
Secondary ID [1] 0 0
ISRCTN85456814
Secondary ID [2] 0 0
Project HORTIS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiation Injuries 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Injuries and Accidents 0 0 0 0
Poisoning
Injuries and Accidents 0 0 0 0
Burns

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SOMA (Subjective, Objective, Management, Analytic) scale used to determine late effects to normal tissue (LENT) score
Timepoint [1] 0 0
pre-treatment, post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
Secondary outcome [1] 0 0
Clinical assessment using one of the following criteria:
Timepoint [1] 0 0
post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
Secondary outcome [2] 0 0
Healed
Timepoint [2] 0 0
post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
Secondary outcome [3] 0 0
Modestly improved (< 50% lesion resolution)
Timepoint [3] 0 0
post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
Secondary outcome [4] 0 0
Not improved
Timepoint [4] 0 0
post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
Secondary outcome [5] 0 0
Other (e.g. lesion recurrence, lesion size progression)
Timepoint [5] 0 0
post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years
Secondary outcome [6] 0 0
Significant Improvement (>50% lesion resolution)
Timepoint [6] 0 0
post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
248
Recruitment in Australia
Recruitment state(s)
QLD,TAS
Recruitment hospital [1] 0 0
Wesley Medical Center - Brisbane
Recruitment hospital [2] 0 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 0 0
4064 - Brisbane
Recruitment postcode(s) [2] 0 0
7001 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
South Carolina
Country [2] 0 0
Mexico
State/province [2] 0 0
Mexico City
Country [3] 0 0
South Africa
State/province [3] 0 0
Cape Town
Country [4] 0 0
South Africa
State/province [4] 0 0
Pretoria
Country [5] 0 0
Turkey
State/province [5] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Other
Name
National Baromedical Services
Address
Country

Ethics approval
Ethics application status

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.)
Trial website
https://clinicaltrials.gov/ct2/show/NCT00134628
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.
Public notes

Contacts
Principal investigator
Name 0 0
Dick Clarke, CHT
Address 0 0
National Baromedical Services
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00134628