Hyperbaric Oxygen Radiation Tissue Injury Study - VII (Laryngeal radionecrosis)

Not Applicable

Completed

• Conditions: Radiation laryngitis; Injury, Occupational Diseases, Poisoning; Unspecified effects of radiation

• Registration Number: ISRCTN01022468
• 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: 42

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
2.3. Telangiectasis
2.4. Oedema
2.5. Pain
2.6. Fistula
2.7. Hoarseness
2.8. Odyrophagia
2.9. Persistent cough
2.10. Airway obstruction
2.11. Airway compromise
2.12. Erythema
2.13. Necrosis
2.14. Cord motility impairment
2.15. Cord fixation
2.16. Tissue hypoxia

Exclusion Criteria

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
<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.