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A Proof-of-principle Study of Hyperbaric Oxygen as a Radiosensitizer Prior to Stereotactic Radiosurgery for Brain Metastases

This study is currently recruiting participants.
Verified August 2016 by Dartmouth-Hitchcock Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01850563
First Posted: May 9, 2013
Last Update Posted: August 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose
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.

Condition Intervention
Brain Metastases Other: Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Proof-of-principle Study of Hyperbaric Oxygen as a Radiosensitizer Prior to Stereotactic Radiosurgery for Brain Metastases

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Statistical Methods for the primary outcome variable of feasibility [ Time Frame: Time line for completion of the study is 3 years. ]

    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.



Estimated Enrollment: 22
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HBO feasibility Other: Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850563


Locations
United States, New Hampshire
Dartmouth-Hitchcock Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Alan Hartford, MD    603-650-6600      
Principal Investigator: Alan Hartford, MD, pHD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Alan Hartford, MD Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01850563     History of Changes
Other Study ID Numbers: D12129
First Submitted: May 7, 2013
First Posted: May 9, 2013
Last Update Posted: August 16, 2016
Last Verified: August 2016

Keywords provided by Dartmouth-Hitchcock Medical Center:
Demonstrate coordination of HBO with SRS treatments is feasible.
Demonstrate outcomes for patients treated with combination of HBO and SRS are non-inferior .

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Brain Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases