BRAIN MALIGNANCIES AFTER RADIATION THERAPY Clinical Trial
Official title:
Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.
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.
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