BRAIN MALIGNANCIES AFTER RADIATION THERAPY Clinical Trial
Official title:
Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.
| Verified date | May 2017 |
| Source | Sheba Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | January 2019 |
| Est. primary completion date | January 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Sheba Medical Center | Ramat Gan |
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center | Assaf-Harofeh Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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. | prior to RT, 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months | |
| Primary | 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 | prior to RT , 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months | |
| Secondary | 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) | Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter | |
| Secondary | 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) | Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter | |
| Secondary | 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) | Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter. |