The purpose of this study is to determine the effectiveness of hyperbaric oxygen therapy (HBOT) as an additional treatment for patients with radionecrosis, a condition that causes tissue damage.

Condition	Treatment or Intervention	Phase
Abnormalities, Radiation Induced	Procedure: Hyperbaric oxygen therapy	Phase II Phase III

A major challenge facing neuro-oncologists is reducing the morbidity and mortality that occur as a side effect of radiation therapy for treating brain tumors. Brain radionecrosis, the most significant complication associated with radiation therapy, comprises various conditions from excessive swelling to tissue death. HBOT, an adjunctive treatment that promotes the development of blood vessels, may be effective in treating the neural tissue of radiation patients.

Participants in this study will be randomly assigned to receive either standard steroid therapy or steroid therapy plus HBOT therapy for 3 months. Brain scans and quality of life questionnaires will be used to assess participants.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Prior brain radiation exposure
• Brain radionecrosis
• Willing to use acceptable methods of contraception (for women of reproductive potential)

Exclusion Criteria:

• Current or previous use of certain medications
• Severe pulmonary disease
• Congestive heart failure
• Pregnancy
• Any condition that could interfere with the study

Carla J. Vogt, RN, BSN      513-558-8165    vogtcr@ucmail.uc.edu

Ohio
      University of Cincinnati Medical Center, Cincinnati,  Ohio,  45267-0769,  United States; Recruiting

Study ID Numbers:  R21 CA10249-01
Record last reviewed:  July 2004
Record first received:  July 14, 2004
ClinicalTrials.gov Identifier:  NCT00087815
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-01