Hyperbaric Oxygen Radiation Tissue Injury Study - IV (Radiation proctitis)

ISRCTN ISRCTN85456814
DOI https://doi.org/10.1186/ISRCTN85456814
ClinicalTrials.gov (NCT) NCT00134628
Protocol serial number N/A
Sponsor Baromedical Research Foundation (USA)
Funders The Lotte and John Hecht Memorial Foundation (Canada), The Gustavus and Louise Pfeiffer Research Foundation (USA), Atlantic Hyperbaric Associates (USA), Mercy Health Partners (USA), Hyperbaric Physician Services (USA), National Baromedical Services (USA)
Submission date
08/04/2005
Registration date
18/05/2005
Last edited
25/01/2019
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Cancer
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

5 Richland Medical Park
Columbia
29203
United States of America

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleHyperbaric Oxygen Radiation Tissue Injury Study - IV (Radiation proctitis)
Study acronymHORTIS - IV
Study objectivesRadiation of prostate, urological and gynecological cancers frequently places the rectum within the radiation portal. Resulting tissue injury will manifest months to years later in a not insignificant percentage of patients. Symptoms include pain, bleeding, bowel dysfunction, stricture, oedema, erythema, tissue friability, ulceration, necrosis and fistulae. Therapeutic approaches include topical agents, transfusions, careful diet, pain control, laser coagulation and surgical resection.

Clinical experience and clinical evidence of a beneficial role of hyperbaric oxygen are generally encouraging but no prospective systematic analysis of outcomes has been reported. HORTIS IV represents the first randomised controlled trial to investigate hyperbaric medicine's therapeutic role at this anatomic site.

Aim:
To determine the effectiveness of hyperbaric oxygen (HBO) therapy as either a prophylaxis against, or treatment of, late radiation tissue injury (RTI).

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)Not provided at time of registration
Health condition(s) or problem(s) studiedRadiation Proctitis
InterventionPatients enrolled in the trial have undergone (and failed to respond to) standard care for a period of not less than 90 days. These patients are included in the trial and assigned to either an active arm (hyperbaric oxygen therapy) or a placebo arm. Patients may require some kind of standard care while in the trial to overcome acute exigiencies (e.g., blood transfusion, surgical cauterisation, etc.).

This trial has been closed to further patient recruitment. The protocol can be found at http://www.baromedicalresearch.org/pdf/HORTISIV_Protocol.pdf.
Intervention typeOther
Primary outcome measure(s)

SOMA (subjective, objective, management, analytic) scale used to determine late effects to normal tissue (LENT) score. Time frame: pre-treatment, post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years.

Key secondary outcome measure(s)

Clinical assessment using one of the following criteria:
1. Healed
2. Modestly improved (less than 50% lesion resolution)
3. Not improved
4. Other (e.g., lesion recurrence, lesion size progression)
5. Significant improvement (greater than 50% lesion resolution)

Time frame: post-treatment (HBO and placebo) and at follow-ups at 3 and 6 months, and 1 year through 5 years

Completion date12/02/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration150
Key inclusion criteriaPatients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the following diagnostic criteria:
1. Endarteritis
2. Hypocellularity
3. Hypovascularity
4. Mucosal thickening
5. Diarrhoea
6. Vomiting
7. Cramping
8. Tenesmus
9. Obstruction
10. Constipation
11. Stricture
12. Perforation
13. Pain
14. Fistula
15. Haemorrhage
16. Obstipation
17. Wall changes
18. Tissue hypoxia
19. Ulceration
Key exclusion criteriaPatients, who are pregnant or have any of the following illnesses, conditions or requirement:
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 enrolment01/01/2001
Date of final enrolment12/02/2005

Locations

Countries of recruitment

  • Australia
  • Mexico
  • South Africa
  • Türkiye
  • United States of America

Study participating centre

5 Richland Medical Park
Columbia
29203
United States of America

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

25/01/2019: Clinicaltrials.gov stated that this trial was terminated by February 2012 due to low accrual

BMC - Part of Springer Nature Springer Nature