Hyperbaric Oxygen Radiation Tissue Injury Study - IV (Radiation proctitis)
| ISRCTN | ISRCTN85456814 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85456814 |
| ClinicalTrials.gov number | NCT00134628 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/04/2005
- Registration date
- 18/05/2005
- Last edited
- 25/01/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Richard Clarke
Scientific
Scientific
5 Richland Medical Park
Columbia
29203
United States of America
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Hyperbaric Oxygen Radiation Tissue Injury Study - IV (Radiation proctitis) |
| Study acronym | HORTIS - IV |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2001 |
| Completion date | 12/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 12/02/2005 |
Locations
Countries of recruitment
- Australia
- Mexico
- South Africa
- Türkiye
- United States of America
Study participating centre
5 Richland Medical Park
Columbia
29203
United States of America
29203
United States of America
Sponsor information
Baromedical Research Foundation (USA)
Charity
Charity
5 Richland Medical Park
Columbia
29203
United States of America
| Website | http://baromedicalresearch.org/ |
|---|
Funders
Funder type
Charity
The Lotte and John Hecht Memorial Foundation (Canada)
No information available
The Gustavus and Louise Pfeiffer Research Foundation (USA)
No information available
Atlantic Hyperbaric Associates (USA)
No information available
Mercy Health Partners (USA)
No information available
Hyperbaric Physician Services (USA)
No information available
National Baromedical Services (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
25/01/2019: Clinicaltrials.gov stated that this trial was terminated by February 2012 due to low accrual
