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Completed

NCT Number: NCT01850563

A Proof-of-principle Study of HBO-SRS 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.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic brain tumor referred to radiation oncology for treatment
  • Size of the presenting metastatic lesion up to 5.0 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 within 14 days to start of study therapy
  • CBC and CMP within 30 days to start of study therapy
  • Chest imaging (Chest Xray or Chest CT) within past 12 months, that does not show any contraindication to hyperbaric therapy (if patient has had any thoracic surgery or other significant event that might have affected the thorax such as trauma, pneumothorax, chest tube insertion, pleurodesis, or thoracentesis and has not had imaging since that event, then the imaging should be repeated).
  • Neurosurgery Consult

Exclusion criteria

  • Pregnant women or women of childbearing potential without adequate contraception. Contraception, which can include abstinence, is required since the last menstrual period until completion of SRS.
  • Evidence of pneumothorax (Untreated pneumothorax risks tension pneumothorax during ascent in HBO chamber)
  • COPD with C02 retention (Such patients can develop respiratory depression as HBO reduces their hypoxemic drive)
  • Uncontrolled seizure disorder (Note that patients on adequate antiepileptic medications may receive HBO)
  • Claustrophobia resistant to medication (Pre-medication with anxiolytics is generally sufficient for almost all anxious patients undergoing HBO treatment)
  • History of middle ear surgery
  • Failure to equalize pressure in the middle ear can cause displacement of middle ear structures with consequent hearing loss
  • To clarify: placement of a tympanostomy tube is not a contraindication to HBO, and in fact may improve tolerability of the procedure
  • History of bleomycin administration (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. (HBO can increase cytotoxicity of cis-platinum)
  • Uncontrolled high blood pressure (HBO can increase systemic vascular resistance)
  • Unstable angina or myocardial infarction within the previous 3 months (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 (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

Treatment and study plan

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

Device

Primary outcomes

  1. The Average Time From HBO Chamber Exit to SRS beam-on

    Time frame: 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 outcomes

  1. Overall Survival in Years

    Time frame: 5 year from treatment

    Median time to death

  2. Number of Years Until Local Recurrence

    Time frame: 5 year from treatment

    Number of years until recurrence of lesion

  3. Number of Years Until Local Recurrence Prior to WBRT

    Time frame: 5 year from treatment

    Number of years until local recurrence of lesion prior to whole brain radiation therapy

  4. Number of Participants Developing Intercranial Distant Recurrence

    Time frame: 5 year from treatment

    Number of participants who developed intercranial distant recurrence

  5. Number of Months Between SRS Treatment and Whole Brain Radiation Therapy

    Time frame: 5 year from treatment

  6. Number of Lesions Exhibiting Radionecrosis

    Time frame: 5 year from treatment

Other outcomes

  1. Average Score of Quality of Life as Measured by St. Louis University Mental Status Exam (SLUMS) Mental Status Exam (SLUMS)

    Time frame: Baseline, 4 to 6 weeks after treatment and then every 3 months for a minimum of 1 year, up to 5 years

    SLUMS is an 11-item screening tool to evaluate cognitive ability in adults. The SLUMS score ranges from 1-30. For patients with a high school education, the normal range score is 27-30. For mild neurocognitive disorder, the score range is 21-26. Dementia range is 1-20. For patients with less than a high school education the normal range score is 25-30. For mild neurocognitive disorder, the score range is 20-24. Dementia range is 1-19.

    The scores across all time points were averaged to obtain the mean.

  2. Average Score of EORTC Global Health Status (QL2)

    Time frame: Baseline, 4 to 6 weeks after treatment and then every 3 months for a minimum of 1 year, up to 5 years

    Averages score QL2 determined by responses to aggregate combined results of questionnaires (QLQ C-30 and BN-20).

    EORTC Quality of Life Questionnaire C-30 (QLQ C-30): 30-item self-report questionnaire rating items on a 4-point scale (1 "not at all" to 4 "very much") It measures several domains (physical, role, emotional, cognitive, and social functioning, fatigue, pain, nausea and vomiting) and several single items. Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better QoL on global health status and functional scales and worse QoL on symptom scales and financial difficulty scale.

    EORTC QLQ BN-20 (BN-20): 4 scales comprised of multiple items and 7 single items. All items are rated on a 4-point Likert-type scale, 1=not at all' to 4=very much, and linearly transformed to a 0-100 scale, higher scores indicating more severe symptoms.

    The scores across all time points were averaged to obtain the mean.

  3. Presence of S100 and NSE (Serum Markers for Tissue Apoptosis and for Neuronal Damage)

    Time frame: 24-48 hours after the SRS treatment

    Serum markers for tissue apoptosis and for neuronal damage

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
May 9, 2013
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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