Hyperbaric Oxygen Radiation Tissue Injury Study - IV (Radiation proctitis)

Not Applicable

Completed

• Conditions: Radiation Proctitis; Radiation tissue injury caused by radiotherapy for cancer; Cancer

• Registration Number: ISRCTN85456814
• Lead Sponsor: Baromedical Research Foundation (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-02-12
• Study Start: 2005-05-18
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> Clinical assessment using one of the following criteria:<br> 1. Healed<br> 2. Modestly improved (less than 50% lesion resolution)<br> 3. Not improved<br> 4. Other (e.g., lesion recurrence, lesion size progression)<br> 5. Significant improvement (greater than 50% lesion resolution)<br><br> Time frame: post-treatment (HBO and placebo) and at follow-ups at 3 and 6 months, and 1 year through 5 years<br>