BRAIN MALIGNANCIES AFTER RADIATION THERAPYNCT01808625
Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.
A study testing HYPERBARIC OXYGEN STIMULATION in people with BRAIN MALIGNANCIES AFTER RADIATION THERAPY, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- BRAIN MALIGNANCIES AFTER RADIATION THERAPY
- What is being tested?
- HYPERBARIC OXYGEN STIMULATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2013to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- HYPERBARIC OXYGEN STIMULATION
- Keywords
- BRAIN MALIGNANCIES , RADIATION THERAPY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYPERBARIC OXYGEN STIMULATIONOther
30 daily sessions, 6 days a week of 90 min exposure to 100% oxygen at 2 ATA.
| Study group | Role | What they receive |
|---|---|---|
| HYPERBARIC OXYGEN STIMULATION | Other | 30 daily sessions, 6 days a week of 90 min exposure to 100% oxygen at 2 atmospheres absolute(ATA). Receives: Other: HYPERBARIC OXYGEN STIMULATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of oxygen stimulation by HBOT, on the changes in QOL of patients with primary and secondary brain malignancies post radiotherapy (RT).
QOL will be evaluated using pre-evaluated known questioners having final score and compare as continuous variable
Measured: prior to RT , 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months
Secondary outcomes (3)
Asses the direct physiological effects of HBOT on the damaged brain tissue, using conventional and novel MRI methodologies.
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)
Measured: 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.
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)
Measured: 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.
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)
Measured: Before RT, at the end of RT, 5 weeks post RT, and every 3 months thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: Tecnical problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRAIN MALIGNANCIES AFTER RADIATION THERAPYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Assaf-Harofeh Medical Center
- Responsible party
- Sponsor
- Investigators
- Leor Zach, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808625
- Sponsor's protocol ID
- SHEBA-12-9756-LZ-CTIL
- Status last verified
- May 2017
- First submitted
- 4 Mar 2013
- Last updated
- 30 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.
- ClinicalTrials.gov ID
- NCT01808625
- Acronym / sponsor ID
- SHEBA-12-9756-LZ-CTIL
- Keywords
- BRAIN MALIGNANCIES , RADIATION THERAPY
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Tecnical problem
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Assaf-Harofeh Medical Center
- Study start
- Mar 2013
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYPERBARIC OXYGEN STIMULATION | Other | Other: HYPERBARIC OXYGEN STIMULATION30 daily sessions, 6 days a week of 90 min exposure to 100% oxygen at 2 atmospheres absolute(ATA). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYPERBARIC OXYGEN STIMULATION30 daily sessions, 6 days a week of 90 min exposure to 100% oxygen at 2 ATA. | Other | HYPERBARIC OXYGEN STIMULATION |
Primary outcome
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
3 secondary outcomes
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
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
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.
Results and safety
The study was stopped early (reason given: Tecnical problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leor Zach, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYPERBARIC OXYGEN STIMULATION in people with BRAIN MALIGNANCIES AFTER RADIATION THERAPY, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Tecnical problem). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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). (time frame: prior to RT , 5 weeks after, and than every 3 months, at the first year post RT, and than every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.