An interventional study of HYPERBARIC OXYGEN STIMULATION in BRAIN MALIGNANCIES AFTER RADIATION THERAPY, sponsored by Sheba Medical Center. Terminated at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Other
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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Exclusion Criteria:
30 daily sessions, 6 days a week of 90 min exposure to 100% oxygen at 2 atmospheres absolute(ATA).
Other: HYPERBARIC OXYGEN STIMULATION
30 daily sessions, 6 days a week of 90 min exposure to 100% oxygen at 2 ATA.
Evaluate the effect of oxygen stimulation by HBOT, on the changes in QOL of patients with primary and secondary brain malignancies post radiotherapy (RT).
QOL will be evaluated using pre-evaluated known questioners having final score and compare as continuous variable
Time frame: prior to RT , 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months
Asses the direct physiological effects of HBOT on the damaged brain tissue, using conventional and novel MRI methodologies.
Standard brain MRI including T1, T2, FLAIR, diffusion weighted imagine (DWI), perfusion weighted imagine (PWI) and T1-Gd and FLAIR sequences. High resolution T1 MRI will be acquired 2, 15 and 75 min post Gd injection for calculation vessel function maps (VFMs)
Time frame: Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter
Asses the direct physiological effects of HBOT on the blood brain barrier (BBB), using conventional and novel MRI methodologies.
Standard brain MRI including T1, T2, FLAIR, diffusion weighted imagine (DWI), perfusion weighted imagine (PWI) and T1-Gd and FLAIR sequences. High resolution T1 MRI will be acquired 2, 15 and 75 min post Gd injection for calculation vessel function maps (VFMs)
Time frame: Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter
Asses the direct physiological effects of HBOT on the micro-circulation using conventional and novel MRI methodologies.
Standard brain MRI including T1, T2, FLAIR, diffusion weighted imagine (DWI), perfusion weighted imagine (PWI) and T1-Gd and FLAIR sequences. High resolution T1 MRI will be acquired 2, 15 and 75 min post Gd injection for calculation vessel function maps (VFMs)
Time frame: Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter.
Evaluate the neurocognitive effect of brain RT on patients with brain malignancies and the ability of HBOT to minimize such effects.
NCF will be evaluated using pre-evaluated computer-based NCF testing.
Time frame: prior to RT, 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center