Condition category
Cancer
Date applied
16/09/2008
Date assigned
17/10/2008
Last edited
03/12/2008
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/soft_tissue_radionecrosis.asp

Contact information

Type

Scientific

Primary contact

Mr Richard Clarke

ORCID ID

Contact details

Baromedical Research Foundation
5 Richland Medical Park
Columbia
29203
United States of America
+1 803 434 7101
dick.clarke@palmettohealth.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00134628

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HORTIS - I

Study hypothesis

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 gynaecology [GYN]). The eighth will investigate the potential of hyperbaric oxygen therapy to prophylax against late radiation tissue injury. This first study HORTIS-I will focus on patients with soft tissue radionecrosis.

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: http://www.controlled-trials.com/isrctn/search.html?srch=HORTIS&sort=3&dir=desc&max=10

Ethics approval

This study was approved by the Palmetto Health, Richland IRB in 2002 (ref: 2002-17).

Study design

Double-blind randomised placebo-controlled multi-centre trial, with cross-over option

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Soft tissue radionecrosis

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

23/02/2001

Overall trial end date

21/07/2012

Reason abandoned

Eligibility

Participant 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. Ulceration
2.6. Dehiscence
2.7. Ischemia
2.8. Necrosis
2.9. Skin graft failure
2.10. Skin flap failure
2.11. Spontaneous breakdown
2.12. Pain
2.13. Delayed healing
2.14. Local Tissue Hypoxia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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 (with the exception of those patients who are immediately [1-5 days] post-operative)
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)

Recruitment start date

23/02/2001

Recruitment end date

21/07/2012

Locations

Countries of recruitment

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

Trial participating centre

Baromedical Research Foundation
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
+1 803 434 7101
ktaylor@baromedicalresearch.org

Sponsor type

Research organisation

Website

http://www.baromedicalresearch.org

Funders

Funder type

Industry

Funder name

National Baromedical Services, Inc (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Lotte and John Hecht Memorial Foundation (Canada)

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