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

NCT00134628 | Terminated Phase 3 DMC

• 2 other identifiers: Project HORTISISRCTN85456814
• Study Type: interventional
• Target: 248
• Locations: 5 countries
• Sites: 7

Brief 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

Keywords

Hyperbaric Oxygenation; Radiation injuries; Prophylaxis; Proctitis; Cystitis; Enteritis; Osteoradionecrosis

Outcome Measures

Primary Outcomes (1)

• SOMA (Subjective, Objective, Management, Analytic) scale used to determine late effects to normal tissue (LENT) score

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

Secondary Outcomes (6)

• Clinical assessment using one of the following criteria:

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

• Healed

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

• Modestly improved (< 50% lesion resolution)

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

• Not improved

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

• Other (e.g. lesion recurrence, lesion size progression)

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

Study Arms (2)

A

ACTIVE COMPARATOR

Hyperbaric Oxygen Therapy

Procedure: Hyperbaric Oxygen Therapy

B

SHAM COMPARATOR

Normal Air

Procedure: Sham treatment

Interventions

Hyperbaric Oxygen Therapy PROCEDURE

HBO at 2.0 ATA

A

Sham treatment PROCEDURE

Normal air under pressure (1.1 ATA)

B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Endarteritis
• Hypovascularity
• Diarrhea
• Cramping
• Obstruction
• Stricture
• Pain
• Hemorrhage
• Wall Changes
• Ulceration
• Hypocellularity
• Mucosal thickening
• Vomiting
• Tenesmus
• Constipation

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Baromedical Services: lead

Study Sites (7)

Palmetto Health Richland

Columbia, South Carolina, 29203, United States

Location

Wesley Medical Center

Brisbane, Queensland, 4064, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7001, Australia

Location

Instituto Nacional de Cancerologica

Mexico City, 14080, Mexico

Location

University of Stellenbosch

Cape Town, South Africa

Location

University of Pretoria Medical Center

Pretoria, 0001, South Africa

Location

Istanbul University Medical Center

Istanbul, 34390, Turkey (Türkiye)

Location

Related Publications (10)

• 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. doi: 10.1016/s0278-2391(97)90478-x.

  PMID: 9191633 BACKGROUND

• Joseph DL, Shumrick DL. Risks of head and neck surgery in previously irradiated patients. Arch Otolaryngol. 1973 May;97(5):381-4. doi: 10.1001/archotol.1973.00780010393005. No abstract available.

  PMID: 4703530 BACKGROUND

• 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. doi: 10.1097/00000637-199311000-00003.

  PMID: 8285524 BACKGROUND

• Hart GB, Mainous EG. The treatment of radiation necrosis with hyperbaric oxygen (OHP). Cancer. 1976 Jun;37(6):2580-5. doi: 10.1002/1097-0142(197606)37:63.0.co;2-h.

  PMID: 949677 BACKGROUND

• Marx RE. Osteoradionecrosis: a new concept of its pathophysiology. J Oral Maxillofac Surg. 1983 May;41(5):283-8. doi: 10.1016/0278-2391(83)90294-x.

  PMID: 6572704 BACKGROUND

• Marx RE. A new concept in the treatment of osteoradionecrosis. J Oral Maxillofac Surg. 1983 Jun;41(6):351-7. doi: 10.1016/s0278-2391(83)80005-6. No abstract available.

  PMID: 6574217 BACKGROUND

• Bevers RF, Bakker DJ, Kurth KH. Hyperbaric oxygen treatment for haemorrhagic radiation cystitis. Lancet. 1995 Sep 23;346(8978):803-5. doi: 10.1016/s0140-6736(95)91620-2.

  PMID: 7674746 BACKGROUND

• 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. doi: 10.1016/s0360-3016(97)00017-5.

  PMID: 9231688 BACKGROUND

• 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. doi: 10.1016/s0002-9378(11)91421-5.

  PMID: 1497044 BACKGROUND

• 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.

  PMID: 8286987 BACKGROUND

MeSH Terms

Conditions

Radiation Injuries; Proctitis; Cystitis; Enteritis; Osteoradionecrosis

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Wounds and Injuries; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Intestinal Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Dick Clarke, CHT

  National Baromedical Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, National Baromedical Research Foundation

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 25, 2005
• Study Start: January 1, 2001
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2012-02

Locations

US (1); AU (2); ME (1); ZA (2); TU (1)