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Complementary Hyperbaric Oxygen for Brain Tissue Damage Caused by Radiation Therapy - Article


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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.

Sponsors and Collaborators: National Center for Complementary and Alternative Medicine (NCCAM)
National Cancer Institute (NCI)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

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

Further Study Details: 

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

Carla J. Vogt, RN, BSN      513-558-8272    support@brainradionecrosis.org.

Ohio
      University of Cincinnati Medical Center, Cincinnati,  Ohio,  45267-0769,  United States; Recruiting
Carla J. Vogt, RN, BSN  513-558-8165    vogtcr@ucmail.uc.edu 
Laurie Beth Gesell, MD,  Principal Investigator

More Information

Click here for more information on brain radionecrosis and hyperbaric medicine.

Study ID Numbers:  R21 CA10249-01
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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Page Updated: October 3, 2005
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