Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087815
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2004-07-14
Brief Title:
Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain
Sponsor:
Barrett Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Complimentary Hyperbaric Oxygen for Brain Radionecrosis
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This randomized clinical trial is studying how well hyperbaric oxygen therapy works in treating patients with radiation necrosis of the brain
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCMC-02101007 | None | None | None |