Soft tissue radionecrosis Cancer Unspecified effects of radiation
Conditions
Sponsors
Baromedical Research Foundation (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females between the ages of 18 and 70 years 2. Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the diagnostic criteria listed below: 2.1. Endarteritis 2.2. Hypocellularity 2.3. Hypovascularity 2.4. Vascular congestion 2.5. Ulceration 2.6. Dehiscence 2.7. Ischemia 2.8. Necrosis 2.9. Skin graft failure 2.10. Skin flap failure 2.11. Spontaneous breakdown 2.12. Pain 2.13. Delayed healing 2.14. Local Tissue Hypoxia
Exclusion criteria
Exclusion criteria: 1. Reactive airway disease 2. Radiographic evidence of pulmonary blebs or bullae 3. Untreated pneumothorax 4. Previously documented ejection fraction less than 35% 5. History of seizures (except childhood febrile seizures) 6. Cardiovascular instability 7. Mechanical ventilator support (with the exception of those patients who are immediately [1-5 days] post-operative) 8. Unable to follow simple commands 9. Not orientated to person, place, time 10. 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 |
|---|---|
| The following will be assessed at pre-treatment, 3 and 6 months, 1, 2, 3, 4 and 5 years post-treatment: 1. Subjective Objective Signs Management and Analysis/Late Effect of Normal Tissue (SOMA/LENT) scores 2. Clinical evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life, assessed by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire at pre-treatment, 3 and 6 months, 1, 2, 3, 4 and 5 years post-treatment. | — |
Countries
Australia, Mexico, South Africa, Turkey, United States of America
Outcome results
None listed