Hyperbaric Oxygen Radiation Tissue Injury Study - III (Radiation cystitis)

Not Applicable

Completed

• Conditions: Radiation cystitis; Urological and Genital Diseases; Cystitis

• Registration Number: ISRCTN19501634
• Lead Sponsor: Baromedical Research Foundation (USA)

Brief Summary

2008 results of one treatment arm in https://www.ncbi.nlm.nih.gov/pubmed/18342453 (added 18/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-12
• Study Completion: 2012-07-21
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

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. Haemorrhage
2.6. Necrosis
2.7. Oedema
2.8. Telangiectasis
2.9. Urgency
2.10. Pain
2.11. Fistula
2.12. Erythema
2.13. Contracted bladder
2.14. Dysplasia
2.15. Vascularity ulceration
2.16. Tissue hypoxia

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
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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified