A Proof-of-principle Study of Hyperbaric Oxygen as a Radiosensitizer Prior to Stereotactic Radiosurgery for Brain Metastases
Conditions
Brain Metastases
Conditions: official terms
Brain Neoplasms - Neoplasm Metastasis
Conditions: 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
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO
Type: Other
Overall Status
Recruiting
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. 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
Status: Recruiting
Contact: Alan Hartford, MD - 603-650-6600
Start Date
May 2013
Completion Date
August 2016
Sponsors
Dartmouth-Hitchcock Medical Center
Source
Dartmouth-Hitchcock Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page