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

This study is currently recruiting participants.
Verified by Baromedical Research Foundation, May 2008

Sponsored by: Baromedical Research Foundation
Information provided by: Baromedical Research Foundation
ClinicalTrials.gov Identifier: NCT00134628
  Purpose

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.)


Condition Intervention Phase
Radiation Injuries
Procedure: Hyperbaric Oxygen Therapy
Procedure: Sham treatment
Phase III

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:   Hyperbaric Oxygen Radiation Tissue Injury Study - Project HORTIS

Further study details as provided by Baromedical Research Foundation:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical assessment using one of the following criteria: [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ] [ Designated as safety issue: No ]
  • Healed [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ] [ Designated as safety issue: No ]
  • Modestly improved (< 50% lesion resolution) [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ] [ Designated as safety issue: No ]
  • Not improved [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ] [ Designated as safety issue: No ]
  • Other (e.g. lesion recurrence, lesion size progression) [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ] [ Designated as safety issue: No ]
  • Significant Improvement (>50% lesion resolution) [ Time Frame: post-treatment (HBO and placebo) and at follow ups at 3 months, 6 months, and 1 year through 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   500
Study Start Date:   January 2001
Estimated Study Completion Date:   August 2010
Estimated Primary Completion Date:   August 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Active Comparator
Hyperbaric Oxygen Therapy
Procedure: Hyperbaric Oxygen Therapy
HBO at 2.0 ATA
B: Sham Comparator
Normal Air
Procedure: Sham treatment
Normal air under pressure (1.1 ATA)

Detailed Description:

Radiation therapy is a key component of the control and eradication of malignant disease. Adequate tumoricidal doses may, however, result in damage to surrounding healthy tissue. Therapeutic radiation injuries to non-target tissues can be divided into acute, sub-acute, and delayed complications. Acute injuries are considered a direct cellular toxicity, self-limiting, and in most cases successfully managed symptomatically. Sub-acute injuries are typically identifiable in only a few organ systems, e.g., radiation pneumonitis. These, too, are generally limited but occasionally evolve to late complications. Late changes occur several months to many years after completing radiotherapy.

The etiology of radiation's late effects to normal tissue (LENT) varies somewhat between organ systems. Its hallmark, however, is one of culminating in an obliterative endarteritis, and local hypoxia.

The incidence of LENT is related to both total radiation exposure and the length of time a patient is out from completing radiotherapy. The higher the dose, the longer the interval from exposure, the greater the risk. In many cases, resulting radionecrotic lesions seriously impair form and function, and require extensive surgical correction or repair. Such surgery is fraught with complications, hence the inclusion of a "prophylactic" hyperbaric oxygen arm. A disturbing degree of mortality further complicates the development of LENT.

Hyperbaric oxygen has been utilized in the treatment of radiation tissue injury for several decades. Most of the supportive basic science and clinical evidence stems from the management of mandibular osteoradionecrosis. More recently, the use of hyperbaric oxygen has been extended to other anatomic sites. This expanded use is based, in large part, on a presumed common underlying pathophysiology of LENT, regardless of its anatomic location. Supportive clinical evidence for these other sites is limited, however, and in need of a greater degree of scientific scrutiny.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Endarteritis
  • Hypovascularity
  • Diarrhea
  • Cramping
  • Obstruction
  • Stricture
  • Pain
  • Hemorrhage
  • Wall Changes
  • Ulceration
  • Hypocellularity
  • Mucosal thickening
  • Vomiting
  • Tenesmus
  • Constipation
  • Perforation
  • Fistula
  • Obstipation
  • Tissue hypoxia

Exclusion Criteria:

  • Pregnancy
  • Reactive airway disease
  • Radiographic evidence of pulmonary blebs or bullae
  • Untreated pneumothorax
  • Previously documented ejection fraction less than 35%
  • History of seizures except childhood febrile seizures
  • Cardiovascular instability
  • Mechanical ventilator support with the exception of those patients who are immediately (1-5 days) post-operative
  • Unable to follow simple commands
  • Not orientated to person, place, time
  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134628

Contacts
Contact: Dick Clarke, CHT     803-434-7101     dick.clarke@palmettohealth.org    
Contact: Samir Desai, MHA     803-434-7101     samir.desai@palmettohealth.org    

Locations
United States, South Carolina
Palmetto Health Richland     Recruiting
      Columbia, South Carolina, United States, 29203
      Contact: Lindsie Cone, MD     803-434-7101     lindsie.cone@palmettohealth.org    
      Sub-Investigator: Lindsie Cone, MD            
Australia, Queensland
Wesley Medical Center     Recruiting
      Brisbane, Queensland, Australia, 4064
      Contact: Robert Long, MD     0733716033     Dr.Long@Wesley.com.au    
      Sub-Investigator: Robert Long, MD            
Australia, Tasmania
Royal Hobart Hospital     Recruiting
      Hobart, Tasmania, Australia, 7001
      Contact: Margaret Walker, MD         margaret.walker@dhhs.tas.gov.au    
      Sub-Investigator: Margaret Walker, MD            
Mexico
Instituto Nacional De Cancerologica     Recruiting
      Mexico City, Mexico, 14080
      Contact: Jose Hinojosa, MD     011 5255 5513 8149     johingom@yahoo.com    
      Sub-Investigator: Catalina Tenorio, MD            
South Africa
University of Pretoria Medical Center     Recruiting
      Pretoria, South Africa, 0001
      Contact: Sylvia Rodriguez, MD     01127123541184     sdsrod@hotmail.com    
      Sub-Investigator: Sylvia Rodriguez, MD            
Turkey
Istanbul University Medical Center     Recruiting
      Istanbul, Turkey, 34390
      Contact: Akin Toklu, MD     902124142200     akin@toklu.net    
      Sub-Investigator: Maide Cimsit, MD            

Sponsors and Collaborators
Baromedical Research Foundation

Investigators
Principal Investigator:     Dick Clarke, CHT     Baromedical Research Foundation    
  More Information


Research activities undertaken by the Baromedical Research Foundation  This link exits the ClinicalTrials.gov site
 

Publications:
Curi MM, Dib LL. Osteoradionecrosis of the jaws: a retrospective study of the background factors and treatment in 104 cases. J Oral Maxillofac Surg. 1997 Jun;55(6):540-4; discussion 545-6.
 
Joseph DL, Shumrick DL. Risks of head and neck surgery in previously irradiated patients. Arch Otolaryngol. 1973 May;97(5):381-4. No abstract available.
 
Samuels L, Granick MS, Ramasastry S, Solomon MP, Hurwitz D. Reconstruction of radiation-induced chest wall lesions. Ann Plast Surg. 1993 Nov;31(5):399-405.
 
Hart GB, Mainous EG. The treatment of radiation necrosis with hyperbaric oxygen (OHP). Cancer. 1976 Jun;37(6):2580-5.
 
Marx RE. Osteoradionecrosis: a new concept of its pathophysiology. J Oral Maxillofac Surg. 1983 May;41(5):283-8.
 
Marx RE. A new concept in the treatment of osteoradionecrosis. J Oral Maxillofac Surg. 1983 Jun;41(6):351-7. No abstract available.
 
Bevers RF, Bakker DJ, Kurth KH. Hyperbaric oxygen treatment for haemorrhagic radiation cystitis. Lancet. 1995 Sep 23;346(8978):803-5.
 
Woo TC, Joseph D, Oxer H. Hyperbaric oxygen treatment for radiation proctitis. Int J Radiat Oncol Biol Phys. 1997 Jun 1;38(3):619-22.
 
Williams JA Jr, Clarke D, Dennis WA, Dennis EJ 3rd, Smith ST. The treatment of pelvic soft tissue radiation necrosis with hyperbaric oxygen. Am J Obstet Gynecol. 1992 Aug;167(2):412-5; discussion 415-6.
 
Feldmeier JJ, Heimbach RD, Davolt DA, Brakora MJ. Hyperbaric oxygen as an adjunctive treatment for severe laryngeal necrosis: a report of nine consecutive cases. Undersea Hyperb Med. 1993 Dec;20(4):329-35.
 

Responsible Party:   The Baromedical Research Foundation ( Director )
Study ID Numbers:   Project HORTIS, ISRCTN85456814
First Received:   August 23, 2005
Last Updated:   May 5, 2008
ClinicalTrials.gov Identifier:   NCT00134628
Health Authority:   United States: Institutional Review Board

Keywords provided by Baromedical Research Foundation:
Hyperbaric Oxygenation  
Radiation injuries  
Prophylaxis  
Proctitis  
Cystitis
Enteritis
Osteoradionecrosis
Prophylaxis

Study placed in the following topic categories:
Enteritis
Wounds and Injuries
Disorders of Environmental Origin
Cystitis
Proctitis
Osteoradionecrosis
Radiation Injuries

ClinicalTrials.gov processed this record on October 17, 2008




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