Radiation prophylaxis 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 are at risk for post-operative healing complications, manifesting as one or more of the medical history or diagnostic criteria listed below: 2.1. High risk for radiation tissue injury/healing complications: 2.1.1. 5,000 cGy (50 Gray or 5,000 rads) radiotherapy and greater than 6 months from completion of radiotherapy 2.1.2. Tissue hypoxia (transcutaneous oximetry recorded below 40 mmHg within the previous radiation portal)
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Ulceration within the previously irradiated field/planned surgical site 3. Reactive airway disease 4. Radiographic evidence of pulmonary blebs or bullae 5. Untreated pneumothorax 6. Ejection fraction less than 35% 7. History of seizures (except childhood febrile seizures) 8. Cardiovascular instability 9. Mechanical ventilator support 10. Unable to follow simple commands 11. Not orientated to person, place, time 12. 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