Clinical trial NCT01808625: Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.
Official title: Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: BRAIN MALIGNANCIES AFTER RADIATION THERAPY
Keywords: BRAIN MALIGNANCIES , RADIATION THERAPY
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Assaf-Harofeh Medical Center
First posted: 2013-03-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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-induced brain inflammation and necrosis inducing secondary cognitive impairments are increasing concerns. Currently there is no effective treatment for preventing long term radiation-induced brain damage.

Hyperbaric oxygen therapy (HBOT) is the administration of high oxygen concentrations within a pressurized chamber to increase the cellular/mitochondrial delivery of oxygen. Oxygen stimulation by HBOT has become the definitive therapy for radiation-induced damage to soft tissues and bone due to its ability to stimulate healing processes by supplying the energy/oxygen needed while down-regulating genes involved in inflammation. Oxygen stimulation by HBOT is currently indicated for patients with overt radiation-induced neurotoxicity and was proven to reduce further development of radiation damage while stimulating "idling" neurons to return to function. Since HBOT is considered safe, we hypothesize that its application following radiation, before the manifestation of neurological side effects, may help avert development of early/delayed onset radiation-induced neurotoxicity.

In the proposed study, for the first time, HBOT will be applied early after radiation to prevent the expected decrease in patients neurocognitive functions (NCF) and improve their quality of life (QOL). The study is designed to provide statistically significant assessment, in a prospective randomized clinical trial, of the effect of oxygen stimulation applied soon after brain radiotherapy, for patients with primary and secondary brain tumors, on patients QOL and NCF. In addition, advanced imaging methodologies will be applied to study the feasibility of quantifying oxygen stimulation effects on the tumor and surrounding brain tissue.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Evaluate the effect of oxygen stimulation by HBOT, on the changes in QOL of patients with primary and secondary brain malignancies post radiotherapy (RT).
timeFrame: prior to RT , 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months
Secondary outcomes:
measure: Asses the direct physiological effects of HBOT on the damaged brain tissue, using conventional and novel MRI methodologies.
timeFrame: Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter
measure: Asses the direct physiological effects of HBOT on the blood brain barrier (BBB), using conventional and novel MRI methodologies.
timeFrame: Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter
measure: Asses the direct physiological effects of HBOT on the micro-circulation using conventional and novel MRI methodologies.
timeFrame: Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter.
Other outcomes:
measure: Evaluate the neurocognitive effect of brain RT on patients with brain malignancies and the ability of HBOT to minimize such effects.
timeFrame: prior to RT, 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Leor Zach, MD
role: PRINCIPAL_INVESTIGATOR
References: