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

NCT ID: NCT01808625

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2019-01-31

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.

Conditions

BRAIN MALIGNANCIES AFTER RADIATION THERAPY

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

HYPERBARIC OXYGEN STIMULATION

30 daily sessions, 6 days a week of 90 min exposure to 100% oxygen at 2 atmospheres absolute(ATA).

Group Type: OTHER

HYPERBARIC OXYGEN STIMULATION

Intervention Type: OTHER

30 daily sessions, 6 days a week of 90 min exposure to 100% oxygen at 2 ATA.

Interventions

HYPERBARIC OXYGEN STIMULATION

30 daily sessions, 6 days a week of 90 min exposure to 100% oxygen at 2 ATA.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leor Zach, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-12-9756-LZ-CTIL

Identifier Type: -

Identifier Source: org_study_id