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Study to Determine if Hyperbaric Oxygen Therapy is Helpful for Treating Radiation Tissue Injuries

NCT00134628 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2016-01-12

No results posted yet for this study

Summary

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 the evaluation of established radionecrosis at varying anatomic sites (mandible, larynx, skin, bladder, rectum, colon, and gyn). The eighth will investigate the potential of hyperbaric oxygen (HBO) therapy to prophylax against late radiation tissue injury.

\*(One of the arms, HORTIS IV - Proctitis has been closed to further patient recruitment. This decision was based on an interim statistical analysis which generated sufficient evidence to support closing down this arm of HORTIS.)

Conditions

  • Radiation Injuries

Interventions

PROCEDURE

Hyperbaric Oxygen Therapy

HBO at 2.0 ATA

PROCEDURE

Sham treatment

Normal air under pressure (1.1 ATA)

Sponsors & Collaborators

  • National Baromedical Services

    lead OTHER

Principal Investigators

  • Dick Clarke, CHT · National Baromedical Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2011-08-31
Completion
2015-12-31

Countries

  • United States
  • Australia
  • Mexico
  • South Africa
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00134628 on ClinicalTrials.gov