Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain

December 17, 2013 updated by: Barrett Cancer Center

Complimentary Hyperbaric Oxygen for Brain Radionecrosis

RATIONALE: Hyperbaric oxygen may increase blood flow and decrease swelling in areas of the brain damaged by radiation therapy. Giving hyperbaric oxygen therapy together with dexamethasone may be an effective treatment for radiation necrosis of the brain.

PURPOSE: This randomized clinical trial is studying how well hyperbaric oxygen therapy works in treating patients with radiation necrosis of the brain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Obtain pilot data demonstrating the potential for increased benefit when complementing conventional steroid therapy with adjunctive hyperbaric oxygen therapy (HBOT) in patients with brain radionecrosis.
  • Estimate the magnitude of benefit of HBOT using objective measures of neurologic function, radiographic imaging, and standardized quality of life measures in these patients.
  • Determine, preliminarily, the effect of HBOT on cerebral revascularization using perfusion MRI in these patients.
  • Determine the feasibility of performing a large-scale, randomized, controlled study (particularly with regard to patient recruitment and retention) comparing HBOT with conventional steroid therapy.

OUTLINE: This is a pilot, randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (conventional care only): Patients receive baseline steroid therapy comprising oral dexamethasone 4 times daily. Steroid doses are either increased or decreased per standard protocol during the 90-day treatment period. Patients who demonstrate neurological deterioration at each evaluation (as evidenced by a decrease in Karnofsky performance status score) receive escalating doses of dexamethasone until the maximum daily dose of 32 mg is reached. Patients who reach the maximum daily dose of dexamethasone are removed from the study. Patients also receive anticonvulsant therapy during study therapy.
  • Arm II (conventional care and hyperbaric oxygen therapy [HBOT]): Patients receive conventional care as in arm I*. Patients also undergo HBOT once daily, 5 days a week, for 90 days (60 treatments total).

NOTE: *Patients in arm II who reach the maximum daily dose of dexamethasone are not removed from the study.

  • Cerebral revascularization study: Five patients from each arm are randomly selected to undergo perfusion MRI before treatment and within 1 week after completion of study therapy to determine the proportion of cerebral neovascularization in each arm.

Patients are evaluated during study by standardized physical examinations, positron emission tomography scans, perfusion MRI, complete neurologic assessment, and standardized, health-related quality of life measures at baseline, at 30-day intervals during treatment, at the end of treatment, and at 1, 2, and 4 months after completion of study therapy.

After completion of study therapy, patients are followed at 1, 2, and 4 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Definitive diagnosis of brain radionecrosis by MRI and positron emission tomography scan

    • Clinically symptomatic with signs of worsening neurologic deficits (e.g., focal deficits or intractable seizures)
  • Condition currently managed with increasing steroid dosage

PATIENT CHARACTERISTICS:

  • No severe pulmonary disease (i.e., untreated pneumothorax, emphysema, chronic obstructive pulmonary disease, or asthma)
  • No active congestive heart failure
  • LVEF ≥ 35%
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychological, familial, sociological, or geographical conditions that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior or concurrent bleomycin
  • No concurrent doxorubicin hydrochloride
  • No concurrent disulfiram

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Vasogenic edema volume by MRI at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment
Lesion volume (contrast enhancement and necrotic core) by MRI at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment
Neurologic status, including mental status, cranial nerves, motor function, sensory function, reflexes, coordination, and gait at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment
Health-related quality of life by Short Form-36 Health Survey and General Well-Being Schedule at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment
Revascularization by perfusion MRI at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment
Survival every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment
Drop-out rate by steroid dosage at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment
Tumor progression by physical examination, positron emission tomography scans, and MRI at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment
Brain radionecrosis progression by MRI at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment
Adverse events (e.g., events related to barotrauma and oxygen or steroid toxicity) at baseline, every 30 days during treatment, at the end of treatment, and then at 1, 2, and 4 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barrett Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Laurie Gesell, MD, Barrett Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

July 14, 2004

First Submitted That Met QC Criteria

July 15, 2004

First Posted (Estimate)

July 16, 2004

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000510427
  • UCMC-02101007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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