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


N/A
18 Years
70 Years
Not Enrolling
Both
BRAIN MALIGNANCIES AFTER RADIATION THERAPY

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Evaluate the effect of oxygen stimulation by HBOT, on the changes in QOL of patients with primary and secondary brain malignancies post radiotherapy (RT).

Outcome Description:

QOL will be evaluated using pre-evaluated known questioners having final score and compare as continuous variable

Outcome Time Frame:

prior to RT , 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months

Safety Issue:

No

Principal Investigator

Leor Zach, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sheba Medical Center

Authority:

Israel: Ministry of Health

Study ID:

SHEBA-12-9756-LZ-CTIL

NCT ID:

NCT01808625

Start Date:

March 2013

Completion Date:

January 2019

Related Keywords:

  • BRAIN MALIGNANCIES AFTER RADIATION THERAPY
  • BRAIN MALIGNANCIES , RADIATION THERAPY
  • Neoplasms

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