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23 May 2012
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| [ Print-friendly version ] |
| Hyperbaric Oxygen Radiation Tissue Injury Study - IV (Radiation proctitis) |
| ISRCTN | ISRCTN85456814 |
| ClinicalTrials.gov identifier | NCT00134628 |
| Public title | Hyperbaric Oxygen Radiation Tissue Injury Study - IV (Radiation proctitis) |
| Scientific title | |
| Acronym | HORTIS - IV |
| Serial number at source | N/A |
| 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 |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Australia, Mexico, South Africa, Turkey, United States of America |
| Disease/condition/study domain | Radiation Proctitis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2001 |
| Anticipated end date | 12/02/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 150 |
| Interventions |
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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding |
1. The Lotte and John Hecht Memorial Foundation (Canada)
2. The Gustavus and Louise Pfeiffer Research Foundation (USA) 3. Atlantic Hyperbaric Associates (USA) 4. Mercy Health Partners (USA) 5. Hyperbaric Physician Services (USA) 6. National Baromedical Services (USA) |
| Trial website | http://www.baromedicalresearch.org/radiation_proctitis.asp |
| Publications | |
| Contact name | Mr Richard Clarke |
| Address | 5 Richland Medical Park |
| City/town | Columbia |
| Zip/Postcode | 29203 |
| Country | United States of America |
| Sponsor | Baromedical Research Foundation (USA) |
| Address | 5 Richland Medical Park |
| City/town | Columbia |
| Zip/Postcode | 29203 |
| Country | United States of America |
| Sponsor website: | http://baromedicalresearch.org/ |
| Date applied | 08/04/2005 |
| Last edited | 07/01/2009 |
| Date ISRCTN assigned | 18/05/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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