Hyperbaric Oxygen Radiation Tissue Injury Study - VII (Laryngeal radionecrosis)
| ISRCTN | ISRCTN01022468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01022468 |
| ClinicalTrials.gov number | NCT00134628 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/09/2008
- Registration date
- 17/10/2008
- Last edited
- 17/01/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Richard Clarke
Scientific
Scientific
Baromedical Research Foundation
5 Richland Medical Park
Columbia
29203
United States of America
| Phone | +1 803 434 7101 |
|---|---|
| dick.clarke@palmettohealth.org |
Study information
| Study design | Double-blind randomised placebo-controlled multi-centre trial, with cross-over option |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Hyperbaric Oxygen Radiation Tissue Injury Study - VII (Laryngeal radionecrosis) |
| Study acronym | HORTIS - VII |
| Study objectives | The principle objective of this research is to more precisely determine the degree of benefit that hyperbaric oxygen therapy affords in the treatment of late radiation tissue injury. The study has eight components. Seven involve evaluation of established radionecrosis at varying anatomic sites (mandible, larynx, skin, bladder, rectum, colon, and GYN). The eighth will investigate the potential of hyperbaric oxygen therapy to prophylax against late radiation tissue injury. This seventh study HORTIS-VII will focus on patients with radiation laryngitis. This study will also generate more precise Benchmarking data as to the complications associated with hyperbaric exposure, including incidence and degree of morbidity. All HORTIS trials that have been registered with ISRCTN can be found at: https://www.isrctn.com/search?q=HORTIS |
| Ethics approval(s) | The study was approved by the Palmetto Health, Richland IRB in 2002 (ref: 2002-17). |
| Health condition(s) or problem(s) studied | Radiation laryngitis |
| Intervention | Patients will be initially randomised 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 of response at specific points during their course of hyperbaric exposure. The total number of exposures will vary from between 20 and 40. Following a 30-day observation/"wash out" period, the allocation assignment will be opened. Patients randomized to the 1.0 ATA air group will be offered the opportunity to cross-over to the 2.0 ATA oxygen arm. The offer is mandatory, not so the requirement of the patient to cross-over. A therapeutic algorithm identical to the first randomization will be undertaken during any subsequent cross-over phase. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 04/02/2004 |
| Completion date | 21/07/2012 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 42 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 04/02/2004 |
| Date of final enrolment | 21/07/2012 |
Locations
Countries of recruitment
- Australia
- Mexico
- South Africa
- Türkiye
- United States of America
Study participating centre
Baromedical Research Foundation
Columbia
29203
United States of America
29203
United States of America
Sponsor information
Baromedical Research Foundation (USA)
Industry
Industry
5 Richland Medical Park
Columbia
29203
United States of America
| Phone | +1 (0)803 434 7101 |
|---|---|
| ktaylor@baromedicalresearch.org | |
| Website | http://www.baromedicalresearch.org |
Funders
Funder type
Industry
National Baromedical Services, Inc (USA)
No information available
The Lotte and John Hecht Memorial Foundation (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2008 | 17/01/2019 | Yes | No |
Editorial Notes
17/01/2019: The trial was stopped due to lack of funding. One arm was completed and published - publication reference added.
