Hyperbaric Oxygen Radiation Tissue Injury Study - VIII (Prophylaxis)
| ISRCTN | ISRCTN46000377 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46000377 |
| ClinicalTrials.gov (NCT) | NCT00134628 |
| Protocol serial number | N/A |
| Sponsor | Baromedical Research Foundation (USA) |
| Funders | National Baromedical Services, Inc. (USA), The Lotte and John Hecht Memorial Foundation (Canada) |
- Submission date
- 16/09/2008
- Registration date
- 17/10/2008
- Last edited
- 17/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised placebo-controlled multi-centre trial, with cross-over option |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Hyperbaric Oxygen Radiation Tissue Injury Study - VIII (Prophylaxis) |
| Study acronym | HORTIS - VIII |
| 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). This eighth study will investigate the potential of hyperbaric oxygen therapy to prophylax against late radiation tissue injury. 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 prophylaxis |
| Intervention | 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 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(s) |
The following will be assessed at pre-treatment, 3 and 6 months, 1, 2, 3, 4 and 5 years post-treatment: |
| Key secondary outcome measure(s) |
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. |
| Completion date | 21/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 38 |
| 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 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) |
| Key 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) |
| Date of first enrolment | 28/09/2001 |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/01/2019: The trial was stopped due to lack of funding. One arm was completed and published - publication reference added.
