Hyperbaric Oxygen Radiation Tissue Injury Study - VIII (Prophylaxis)

Not Applicable

Completed

• Conditions: Radiation prophylaxis; Cancer; Unspecified effects of radiation

• Registration Number: ISRCTN46000377
• Lead Sponsor: Baromedical Research Foundation (USA)

Brief Summary

2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18342453 [added 17/01/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-17
• Study Completion: 2012-07-21
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The following will be assessed at pre-treatment, 3 and 6 months, 1, 2, 3, 4 and 5 years post-treatment:<br> 1. Subjective Objective Signs Management and Analysis/Late Effect of Normal Tissue (SOMA/LENT) scores<br> 2. Clinical evaluation<br>

Secondary Outcome Measures

Name	Time	Method
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.