A Proof-of-principle Study of Hyperbaric Oxygen as a Radiosensitizer Prior to Stereotactic Radiosurgery for Brain Metastases
18 Years
80 Years
Both
Brain Metastases
Trial Information
A Proof-of-principle Study of Hyperbaric Oxygen as a Radiosensitizer Prior to Stereotactic Radiosurgery for Brain Metastases
Inclusion Criteria:
- Metastatic brain tumor referred to radiation oncology for treatment
- Size of the presenting metastatic lesion up to 4.5 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
prior to start of study therapy
Exclusion Criteria:
Patients with the following conditions are not eligible to participate in this trial:
- Pregnant women or women of childbearing potential without adequate contraception
- Evidence of pneumothorax
o Untreated pneumothorax risks tension pneumothorax during ascent in HBO chamber
- COPD with C02 retention
o Such patients can develop respiratory depression as HBO reduces their hypoxemic
drive
- Uncontrolled seizure disorder
o Note that patients on adequate antiepileptic medications may receive HBO
- Claustrophobia resistant to medication
o Pre-medication with anxiolytics is generally sufficient for almost all anxious
patients undergoing HBO treatment
- History of middle ear surgery o Failure to equalize pressure in the middle ear can
cause displacement of middle ear structures with consequent hearing loss
- History of bleomycin administration
o 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)
o HBO can increase cytotoxicity of cis-platinum
- Uncontrolled high blood pressure
o HBO can increase systemic vascular resistance
- Unstable angina or myocardial infarction within the previous 3 months
o 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
o 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Statistical Methods for the primary outcome variable of feasibility
Outcome Description:
For the primary outcome variable of feasibility,the 20 evaluable patients will be analyzed on the basis of the amount of time required from leaving the HBO chamber to beginning the SRS for the target lesion(T1).The goal for each patient is for T1 to be no greater than 15 minutes.We anticipate a learning curve for the team members of this study. The primary endpoint of 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:in other words,T1 is <=30minutes >50% of evaluable patients.
Outcome Time Frame:
Time line for completion of the study is 3 years.
Safety Issue:
No
Authority:
United States: Data and Safety Monitoring Board
Study ID:
D12129
NCT ID:
NCT01850563
Start Date:
May 2013
Completion Date:
August 2016
Related Keywords:
- Brain Metastases
- To demonstrate that coordination of HBO with SRS treatments is feasible.
- To demonstrate that outcomes for patients treated with combination of HBO and SRS are non-inferior to historical controls.
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Brain Neoplasms
Name | Location |
|---|---|
| Dartmouth-Hitchcock | Lebanon, New Hampshire 03756 |
