Radiation Therapy |
Brachytherapy; Radiofrequency Ablation; Radiosurgery |
Clinical Trial: Complementary Hyperbaric Oxygen for Brain Tissue Damage Caused by Radiation Therapy
This study is currently recruiting patients.
|
Purpose
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 |
MedlinePlus related topics: Birth Defects
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Complementary Hyperbaric Oxygen for Brain Radionecrosis
Expected Total Enrollment: 30
Study start: September 2003; Expected completion: June 2005
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.
Eligibility
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
Location and Contact Information
Ohio
University of Cincinnati Medical Center, Cincinnati, Ohio, 45267-0769, United States; Recruiting
Laurie Beth Gesell, MD, Principal Investigator
More Information
Click here for more information on brain radionecrosis and hyperbaric medicine.
Record last reviewed: March 2005
Last Updated: March 24, 2005
Record first received: July 14, 2004
ClinicalTrials.gov Identifier: NCT00087815
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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