Radiation Proctitis Cancer Radiation tissue injury caused by radiotherapy for cancer
Conditions
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
Sponsors
Baromedical Research Foundation (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia, Mexico, South Africa, Turkey, United States of America
Outcome results
None listed