Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.

May 24, 2017 updated by: Sheba Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: HYPERBARIC OXYGEN STIMULATION
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of oxygen stimulation by HBOT, on the changes in QOL of patients with primary and secondary brain malignancies post radiotherapy (RT).
Time Frame: prior to RT , 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asses the direct physiological effects of HBOT on the damaged brain tissue, using conventional and novel MRI methodologies.
Time Frame: Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter
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
Asses the direct physiological effects of HBOT on the blood brain barrier (BBB), using conventional and novel MRI methodologies.
Time Frame: Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter
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
Asses the direct physiological effects of HBOT on the micro-circulation using conventional and novel MRI methodologies.
Time Frame: Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the neurocognitive effect of brain RT on patients with brain malignancies and the ability of HBOT to minimize such effects.
Time Frame: prior to RT, 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Leor Zach, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

January 1, 2018

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (ESTIMATE)

March 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-12-9756-LZ-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on BRAIN MALIGNANCIES AFTER RADIATION THERAPY

Clinical Trials on HYPERBARIC OXYGEN STIMULATION

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe