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

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ClinicalTrials.gov Identifier: NCT01808625
Recruitment Status : Terminated (Tecnical problem)
First Posted : March 11, 2013
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Assaf-Harofeh Medical Center
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
BRAIN MALIGNANCIES AFTER RADIATION THERAPY Other: HYPERBARIC OXYGEN STIMULATION Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.
Study Start Date : March 2013
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808625


Locations
Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Leor Zach, MD Sheba Medical Center

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01808625     History of Changes
Other Study ID Numbers: SHEBA-12-9756-LZ-CTIL
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Sheba Medical Center:
BRAIN MALIGNANCIES , RADIATION THERAPY

Additional relevant MeSH terms:
Neoplasms