Condition category
Cancer
Date applied
08/04/2005
Date assigned
18/05/2005
Last edited
07/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.baromedicalresearch.org/radiation_proctitis.asp

Contact information

Type

Scientific

Primary contact

Mr Richard Clarke

ORCID ID

Contact details

5 Richland Medical Park
Columbia
29203
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00134628

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HORTIS - IV

Study hypothesis

Radiation 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Radiation Proctitis

Intervention

Patients 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/01/2001

Overall trial end date

12/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Patients, 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

Recruitment start date

01/01/2001

Recruitment end date

12/02/2005

Locations

Countries of recruitment

Australia, Mexico, South Africa, Turkey, United States of America

Trial participating centre

5 Richland Medical Park
Columbia
29203
United States of America

Sponsor information

Organisation

Baromedical Research Foundation (USA)

Sponsor details

5 Richland Medical Park
Columbia
29203
United States of America

Sponsor type

Charity

Website

http://baromedicalresearch.org/

Funders

Funder type

Charity

Funder name

The Lotte and John Hecht Memorial Foundation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Gustavus and Louise Pfeiffer Research Foundation (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Atlantic Hyperbaric Associates (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Mercy Health Partners (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hyperbaric Physician Services (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Baromedical Services (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes