A Proof-of-principle Study of Hyperbaric Oxygen as a Radiosensitizer Prior to Stereotactic Radiosurgery for Brain Metastases
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/10/2019 |
| Start Date: | July 1, 2013 |
| End Date: | February 2020 |
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.
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.
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
We found this trial at
1
site
Lebanon, New Hampshire 03756
Principal Investigator: Alan Hartford, MD, pHD
Phone: 603-650-6600
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