Hyperbaric Oxygen Radiation Tissue Injury Study - III (Radiation cystitis)

ISRCTN	ISRCTN19501634
DOI	https://doi.org/10.1186/ISRCTN19501634
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: 12/11/2008
Last edited: 18/01/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Urological and Genital Diseases

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

Baromedical Research Foundation
5 Richland Medical Park
Columbia
29203
United States of America

Phone	+1 803 434 7101
Email	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 treatment of chronic refractory radiation proctitis: a randomized and controlled double-blind crossover trial with long-term follow-up
Study acronym	HORTIS - III
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 gynecology [GYN]). The eighth will investigate the potential of hyperbaric oxygen therapy to prophylax against late radiation tissue injury. This third study HORTIS-III will focus on patients with radiation cystitis. This study will also generate more precise "Benchmarking" data as to the complications associated with hyperbaric exposure, including incidence and degree of morbidity. Overview of the study can be found at: http://www.baromedicalresearch.org/pdf/HORTIS_Overview.pdf All HORTIS trials that have been registered with ISRCTN can be found at: http://www.controlled-trials.com/isrctn/search.html?srch=HORTIS&sort=3&dir=desc&max=10
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 cystitis
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: 1. Subjective Objective Signs Management and Analysis/Late Effect of Normal Tissue (SOMA/LENT) scores 2. Clinical evaluation
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
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	32
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 2.5. Haemorrhage 2.6. Necrosis 2.7. Oedema 2.8. Telangiectasis 2.9. Urgency 2.10. Pain 2.11. Fistula 2.12. Erythema 2.13. Contracted bladder 2.14. Dysplasia 2.15. Vascularity ulceration 2.16. Tissue hypoxia
Key exclusion criteria	1. Reactive airway disease 2. Radiographic evidence of pulmonary blebs or bullae 3. Untreated pneumothorax 4. Previously documented ejection fraction less than 35% 5. History of seizures (except childhood febrile seizures) 6. Cardiovascular instability 7. Mechanical ventilator support 8. Unable to follow simple commands 9. Not orientated to person, place, time 10. 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	21/07/2003
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

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 of one treatment arm	01/09/2008	18/01/2019	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

18/01/2019: The following changes have been made to the trial record:
1. Publication reference added
2. Study abandoned due to a lack of funding
3. Scientific title added