Brain MetastasesNCT01850563
A Proof-of-principle Study of HBO-SRS for Brain Metastases
A study testing Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO in people with Brain Metastases, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Patients with brain metastases who are candidates for treatment with stereotactic radiosurgery (SRS) are potential study participants. SRS delivers high-energy, precisely-focused radiation to each brain metastasis to shrink the tumor, and is the standard-of-care for patients with these tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2013to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic brain tumor referred to radiation oncology for treatment
- Size of the presenting metastatic lesion up to 5.0 cm diameter
- Age > 18 years
- Patients must give informed consent indicating they are aware of the investigational nature of this treatment
- Karnofsky Performance Status > 70% (Zubrod score 0 to 1)
- Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days to start of study therapy
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- CBC and CMP within 30 days to start of study therapy
- Chest imaging (Chest Xray or Chest CT) within past 12 months, that does not show any contraindication to hyperbaric therapy (if patient has had any thoracic surgery or other significant event that might have affected the thorax such as trauma, pneumothorax, chest tube insertion, pleurodesis, or thoracentesis and has not had imaging since that event, then the imaging should be repeated).
- Neurosurgery Consult
Who cannot join
- Pregnant women or women of childbearing potential without adequate contraception. Contraception, which can include abstinence, is required since the last menstrual period until completion of SRS.
- Evidence of pneumothorax (Untreated pneumothorax risks tension pneumothorax during ascent in HBO chamber)
- COPD with C02 retention (Such patients can develop respiratory depression as HBO reduces their hypoxemic drive)
- Uncontrolled seizure disorder (Note that patients on adequate antiepileptic medications may receive HBO)
- Claustrophobia resistant to medication (Pre-medication with anxiolytics is generally sufficient for almost all anxious patients undergoing HBO treatment)
- History of middle ear surgery
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- Failure to equalize pressure in the middle ear can cause displacement of middle ear structures with consequent hearing loss
- To clarify: placement of a tympanostomy tube is not a contraindication to HBO, and in fact may improve tolerability of the procedure
- History of bleomycin administration (HBO can exacerbate interstitial pneumonitis in such patients)
- Current cis-platinum chemotherapy, i.e. therapeutic levels in the bloodstream at the time of HBO therapy. (HBO can increase cytotoxicity of cis-platinum)
- Uncontrolled high blood pressure (HBO can increase systemic vascular resistance)
- Unstable angina or myocardial infarction within the previous 3 months (Increased afterload due to HBO can increase myocardial workload)
- Cardiac EF ≤ 35%
- Pulmonary edema can arise with HBO in certain patients with severe heart failure
- In patients with prior history of CHF, subsequent echocardiogram and ECG are required to establish EF>35%
- Treatment with disulfiram (Disulfiram inhibits superoxide dismutase and is not approved for use concomitantly with hyperbaric oxygen therapy)
- Active drug/alcohol dependence or abuse
- Lack of adequate social support structures, e.g. homelessness
- Tumors with potential confounding results on serum marker studies
- Small cell (neuroendocrine) carcinomas
- Carcinoid tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-principle Study of Hyperbaric Oxygen as a Radiosensitizer Prior to Stereotactic Radiosurgery for Brain Metastases
Patients with brain metastases who are candidates for treatment with stereotactic radiosurgery (SRS) are potential study participants. SRS delivers high-energy, precisely-focused radiation to each brain metastasis to shrink the tumor, and is the standard-of-care for patients with these tumors. Oxygen enhances the damaging effects of radiation on tumor cells. Hyperbaric oxygen (HBO) therapy increases oxygen levels in all kinds of tissues, including tumors. The purpose of this trial is to study whether it is feasible to treat patients with HBO just prior to receiving SRS, given the timing constraints of treating sequentially with HBO and then SRS. Patients will undergo HBO treatment followed by the placement of a Gill-Thomas-Cosman head frame then transported ,via stretcher, to receive SRS. The transfer and placement of the head frame needs to be completed within the 15minute time frame. The trial's secondary objectives are to determine whether it has any effects on outcomes and quality of life. As part of study participation patients will be asked to complete quality of life questionnaires as well as mini mental status questionnaires. These will be done prior to treatment and at follow up appointments throughout the next 3 years while participating in the study. Patients will be given the option to participate in the optional bio marker blood draw study which would require patients to have blood drawn at three time points, pre-treatment, the day after treatment and at their first follow up visit.
- Conditions
- Brain Metastases
- Being tested
- Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO
- Keywords
- Demonstrate coordination of HBO with SRS treatments is feasible., Demonstrate outcomes for patients treated with combination of HBO and SRS are non-inferior .
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBODevice
| Study group | Role | What they receive |
|---|---|---|
| HBO feasibility | Other | Not described Receives: Device: Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Average Time From HBO Chamber Exit to SRS beam-on
Time from end of HBO decompression to start of SRS treatment will be measured to determine feasibility. Feasibility is defined as having been achieved if more than 50% of the 20 evaluable patients start SRS treatment within 30 minutes of leaving the HBO tank
Measured: Approximately 30 minutes during SRS Treatment Visit
Secondary outcomes (6)
Overall Survival in Years
Median time to death
Measured: 5 year from treatment
Number of Years Until Local Recurrence
Number of years until recurrence of lesion
Measured: 5 year from treatment
Number of Years Until Local Recurrence Prior to WBRT
Number of years until local recurrence of lesion prior to whole brain radiation therapy
Measured: 5 year from treatment
Number of Participants Developing Intercranial Distant Recurrence
Number of participants who developed intercranial distant recurrence
Measured: 5 year from treatment
Number of Months Between SRS Treatment and Whole Brain Radiation Therapy
Measured: 5 year from treatment
Number of Lesions Exhibiting Radionecrosis
Measured: 5 year from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study start1 Jul 2013
- Primary completion3 Oct 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Hartford, Dartmouth-Hitchcock Medical Center
- Investigators
- Alan Hartford, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850563
- Sponsor's protocol ID
- D12129
- Status last verified
- Jan 2022
- First submitted
- 7 May 2013
- Last updated
- 8 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Hartford AC, Gill GS, Ravi D, Tosteson TD, Li Z, Russo G, Eskey CJ, Jarvis LA, Simmons NE, Evans LT, Williams BB, Gladstone DJ, Roberts DW, Buckey JC Jr. Sensitizing brain metastases to stereotactic radiosurgery using hyperbaric oxygen: A proof-of-principle study. Radiother Oncol. 2022 Dec;177:179-184. doi: 10.1016/j.radonc.2022.10.024. Epub 2022 Oct 28.
PubMed 36404528
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-principle Study of Hyperbaric Oxygen as a Radiosensitizer Prior to Stereotactic Radiosurgery for Brain Metastases
- ClinicalTrials.gov ID
- NCT01850563
- Acronym / sponsor ID
- D12129
- Conditions
- Brain Metastases
- Keywords
- Demonstrate coordination of HBO with SRS treatments is feasible., Demonstrate outcomes for patients treated with combination of HBO and SRS are non-inferior .
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Posted 29 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with brain metastases who are candidates for treatment with stereotactic radiosurgery (SRS) are potential study participants. SRS delivers high-energy, precisely-focused radiation to each brain metastasis to shrink the tumor, and is the standard-of-care for patients with these tumors. Oxygen enhances the damaging effects of radiation on tumor cells. Hyperbaric oxygen (HBO) therapy increases oxygen levels in all kinds of tissues, including tumors. The purpose of this trial is to study whether it is feasible to treat patients with HBO just prior to receiving SRS, given the timing constraints of treating sequentially with HBO and then SRS. Patients will undergo HBO treatment followed by the placement of a Gill-Thomas-Cosman head frame then transported ,via stretcher, to receive SRS. The transfer and placement of the head frame needs to be completed within the 15minute time frame. The trial's secondary objectives are to determine whether it has any effects on outcomes and quality of life. As part of study participation patients will be asked to complete quality of life questionnaires as well as mini mental status questionnaires. These will be done prior to treatment and at follow up appointments throughout the next 3 years while participating in the study. Patients will be given the option to participate in the optional bio marker blood draw study which would require patients to have blood drawn at three time points, pre-treatment, the day after treatment and at their first follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBO feasibility | Other | Device: Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Metastatic brain tumor referred to radiation oncology for treatment
- Size of the presenting metastatic lesion up to 5.0 cm diameter
- Age > 18 years
- Patients must give informed consent indicating they are aware of the investigational nature of this treatment
- Karnofsky Performance Status > 70% (Zubrod score 0 to 1)
Key exclusion criteria (21 listed)
- Pregnant women or women of childbearing potential without adequate contraception. Contraception, which can include abstinence, is required since the last menstrual period until completion of SRS.
- Evidence of pneumothorax (Untreated pneumothorax risks tension pneumothorax during ascent in HBO chamber)
- COPD with C02 retention (Such patients can develop respiratory depression as HBO reduces their hypoxemic drive)
- Uncontrolled seizure disorder (Note that patients on adequate antiepileptic medications may receive HBO)
- Claustrophobia resistant to medication (Pre-medication with anxiolytics is generally sufficient for almost all anxious patients undergoing HBO treatment)
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 given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO | Device | HBO feasibility |
Primary outcome
The Average Time From HBO Chamber Exit to SRS beam-on
Time frame: Approximately 30 minutes during SRS Treatment Visit
Time from end of HBO decompression to start of SRS treatment will be measured to determine feasibility. Feasibility is defined as having been achieved if more than 50% of the 20 evaluable patients start SRS treatment within 30 minutes of leaving the HBO tank
6 secondary outcomes
Overall Survival in Years
Time frame: 5 year from treatment
Number of Years Until Local Recurrence
Time frame: 5 year from treatment
Number of Years Until Local Recurrence Prior to WBRT
Time frame: 5 year from treatment
Number of Participants Developing Intercranial Distant Recurrence
Time frame: 5 year from treatment
Number of Months Between SRS Treatment and Whole Brain Radiation Therapy
Time frame: 5 year from treatment
Number of Lesions Exhibiting Radionecrosis
Time frame: 5 year from treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36404528Hartford AC, Gill GS, Ravi D, Tosteson TD, Li Z, Russo G, Eskey CJ, Jarvis LA, Simmons NE, Evans LT, Williams BB, Gladstone DJ, Roberts DW, Buckey JC Jr. Sensitizing brain metastases to stereotactic radiosurgery using hyperbaric oxygen: A proof-of-principle study. Radiother Oncol. 2022 Dec;177:179-184. doi: 10.1016/j.radonc.2022.10.024. Epub 2022 Oct 28.
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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.
Alan Hartford, MD principal investigator
Dartmouth-Hitchcock 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 given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO in people with Brain Metastases, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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 9 inclusion and 21 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: finished, as of the sponsor's last update on 8 Feb 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Average Time From HBO Chamber Exit to SRS beam-on (time frame: Approximately 30 minutes during SRS Treatment Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850563, which also lists 1 linked publication.
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 8 Feb 2022.