Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00134628
Protocol/serial number
N/A
Study information
Scientific title
Hyperbaric Oxygen Radiation Tissue Injury Study - IV (Radiation proctitis)
Acronym
HORTIS - IV
Study hypothesis
Radiation of prostate, urological and gynecological cancers frequently places the rectum within the radiation portal. Resulting tissue injury will manifest months to years later in a not insignificant percentage of patients. Symptoms include pain, bleeding, bowel dysfunction, stricture, oedema, erythema, tissue friability, ulceration, necrosis and fistulae. Therapeutic approaches include topical agents, transfusions, careful diet, pain control, laser coagulation and surgical resection.
Clinical experience and clinical evidence of a beneficial role of hyperbaric oxygen are generally encouraging but no prospective systematic analysis of outcomes has been reported. HORTIS IV represents the first randomised controlled trial to investigate hyperbaric medicine's therapeutic role at this anatomic site.
Aim:
To determine the effectiveness of hyperbaric oxygen (HBO) therapy as either a prophylaxis against, or treatment of, late radiation tissue injury (RTI).
Overview of the study can be found at: http://www.baromedicalresearch.org/pdf/HORTIS_Overview.pdf
All HORTIS trials that have been registered with ISRCTN can be found at: http://www.controlled-trials.com/isrctn/search.html?srch=HORTIS&sort=3&dir=desc&max=10
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Radiation Proctitis
Intervention
Patients enrolled in the trial have undergone (and failed to respond to) standard care for a period of not less than 90 days. These patients are included in the trial and assigned to either an active arm (hyperbaric oxygen therapy) or a placebo arm. Patients may require some kind of standard care while in the trial to overcome acute exigiencies (e.g., blood transfusion, surgical cauterisation, etc.).
This trial has been closed to further patient recruitment. The protocol can be found at http://www.baromedicalresearch.org/pdf/HORTISIV_Protocol.pdf.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
SOMA (subjective, objective, management, analytic) scale used to determine late effects to normal tissue (LENT) score. Time frame: pre-treatment, post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years.
Secondary outcome measures
Clinical assessment using one of the following criteria:
1. Healed
2. Modestly improved (less than 50% lesion resolution)
3. Not improved
4. Other (e.g., lesion recurrence, lesion size progression)
5. Significant improvement (greater than 50% lesion resolution)
Time frame: post-treatment (HBO and placebo) and at follow-ups at 3 and 6 months, and 1 year through 5 years
Overall trial start date
01/01/2001
Overall trial end date
12/02/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the following diagnostic criteria:
1. Endarteritis
2. Hypocellularity
3. Hypovascularity
4. Mucosal thickening
5. Diarrhoea
6. Vomiting
7. Cramping
8. Tenesmus
9. Obstruction
10. Constipation
11. Stricture
12. Perforation
13. Pain
14. Fistula
15. Haemorrhage
16. Obstipation
17. Wall changes
18. Tissue hypoxia
19. Ulceration
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
Patients, who are pregnant or have any of the following illnesses, conditions or requirement:
1. Pregnancy
2. Reactive airway disease
3. Radiographic evidence of pulmonary blebs or bullae
4. Untreated pneumothorax
5. Previously documented ejection fraction less than 35%
6. History of seizures - except childhood febrile seizures
7. Cardiovascular instability
8. Mechanical ventilator support
9. Unable to follow simple commands
10. Not orientated to person, place, time
11. 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
Recruitment start date
01/01/2001
Recruitment end date
12/02/2005
Locations
Countries of recruitment
Australia, Mexico, South Africa, Turkey, United States of America
Trial participating centre
5 Richland Medical Park
Columbia
29203
United States of America
Sponsor information
Organisation
Baromedical Research Foundation (USA)
Sponsor details
5 Richland Medical Park
Columbia
29203
United States of America
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
The Lotte and John Hecht Memorial Foundation (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Gustavus and Louise Pfeiffer Research Foundation (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Atlantic Hyperbaric Associates (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Mercy Health Partners (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Hyperbaric Physician Services (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Baromedical Services (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list