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.
View more details from ClinicalTrials.gov.
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