Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.
HYPERBARIC OXYGEN STIMULATION
Other Study
Summary
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location