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

Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a randomized and controlled double-blind crossover trial with long-term follow-up

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19501634

Enrollment

Registered

2008-11-12

Start date

2003-07-21

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation cystitis Urological and Genital Diseases Cystitis

Interventions

Patients will be initially randomized to receive either oxygen at 2.0 atmospheres absolute (ATA), or air at 1.0 ATA. The therapeutic algorithm is personalized to each patient's degree

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. 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

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)

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

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026