A Proof-of-principle Study of HBO-SRS for Brain Metastases

Not Applicable

Completed

• Conditions: Brain Metastases
• Interventions: Device: Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO

• Registration Number: NCT01850563
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-09
• Study Start: 2013-07-01
• Primary Completion: 2019-10-03
• Study Completion: 2020-02-28
• Results First Submitted: 2021-04-27
• Results First Submitted QC: 2021-07-09
• Results First Posted: 2021-07-29
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HBO feasibility	Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO	-

Primary Outcome Measures

Name	Time	Method
The Average Time From HBO Chamber Exit to SRS beam-on	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival in Years	5 year from treatment	Median time to death
Number of Years Until Local Recurrence	5 year from treatment	Number of years until recurrence of lesion
Number of Years Until Local Recurrence Prior to WBRT	5 year from treatment	Number of years until local recurrence of lesion prior to whole brain radiation therapy
Number of Participants Developing Intercranial Distant Recurrence	5 year from treatment	Number of participants who developed intercranial distant recurrence
Number of Months Between SRS Treatment and Whole Brain Radiation Therapy	5 year from treatment
Number of Lesions Exhibiting Radionecrosis	5 year from treatment

Trial Locations

Locations (1)

Dartmouth-Hitchcock; 🇺🇸 Lebanon, New Hampshire, United States