Suspended

Complimentary Hyperbaric Oxygen for Brain Radionecrosis

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What is being tested

Data Collection

Who is being recruted

Neoplasms
+2

+ Neoplasms by Site
+ Nervous System Diseases
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorBarrett Cancer Center
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleComplimentary Hyperbaric Oxygen for Brain Radionecrosis 
NCT00087815
Principal SponsorBarrett Cancer Center
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Central Nervous System Neoplasms
Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Cincinnati Medical CenterCincinnati, United StatesSee the location
SuspendedOne Study Center