Status:
TERMINATED
Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
Assaf-Harofeh Medical Center
Conditions:
BRAIN MALIGNANCIES AFTER RADIATION THERAPY
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Radiotherapy is the mainstay of treatment for brain malignancies and is associated with significant neurotoxicity. Due to continuous increase in patient's survival, the long term risk for radiation-in...
Eligibility Criteria
Inclusion
- Newly diagnosed pathologically confirmed Glioblastoma Multiforme (GBM) (WHO grade IV glioma) planned to receive brain RT with temozolomide(TMZ), or patients with pathologically confirmed breast or Non Small Cell Lung Cancer (NSCLC) with \>3 brain metastases as identified on contrast-enhanced brain MRI or CT, planned to receive whole-brain radiotherapy(WBRT) recursive partitioning analysis (RPA) class I or class II.
- Karnofsky performance status (KPS) of \>=70%
- Controlled systemic disease
Exclusion
- Previous treatment with HBOT for any other reason during the last 3 months prior to inclusion.
- Any new chemotherapy or RT intervention during the first 5 weeks after RT.
- Patients with chest pathology incompatible with pressure changes, inner ear disease or claustrophobia.
- Active Smoker
- Pre- existing or active psychiatric or neurologic impairments, not caused by the brain malignancy which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol.
- Previous cranial irradiation treatment.
- Previous treatment with an investigational drug for the primary disease within 14 days of baseline neuropsychological testing.
- Patients who have had surgery for their current brain malignancy must wait at least 14 days before baseline neuropsychological testing.
- Lepto-meningeal spread.
- Pregnancy or breast-feeding.
- Medical conditions deemed by the investigator to make the patient ineligible for protocol investigations.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01808625
Start Date
March 1 2013
End Date
January 1 2019
Last Update
May 30 2017
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel