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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Stopped early
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00134628