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A Proof-of-principle Study of HBO-SRS for Brain Metastases
NA trial testing Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO in Brain Metastases in 22 participants. Completed in 28 February 2020.
| Lead sponsor | Dartmouth-Hitchcock Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 1 July 2013 |
| Primary completion | 3 October 2019 |
| Estimated completion | 28 February 2020 |
| Sites | 1 location across United States |
Dartmouth-Hitchcock Medical Center
Adults 18 to 80, any sex, with Brain Metastases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| HBO Feasibility | 8.3 | 5 – 12 |
Median time to death
| Group | Value | 95% CI |
|---|---|---|
| HBO Feasibility | 1.42 | 0.96 – 2.35 |
| Historic Controls | 1.03 | 0.57 – 2.80 |
Number of years until recurrence of lesion
| Group | Value | 95% CI |
|---|---|---|
| HBO Feasibility | NA | 1.45 – NA |
| Historic Controls | NA | 0.70 – NA |
Number of years until local recurrence of lesion prior to whole brain radiation therapy
| Group | Value | 95% CI |
|---|---|---|
| HBO Feasibility | NA | 1.45 – NA |
| Historic Controls | NA | 0.70 – NA |
Number of participants who developed intercranial distant recurrence
| Group | Value | 95% CI |
|---|---|---|
| HBO Feasibility | 9 | |
| Historic Controls | 11 |
| Group | Value | 95% CI |
|---|---|---|
| HBO Feasibility | 8.5 | 1.5 – 23.3 |
| Historic Controls | 5.6 | 4.7 – 6.5 |
| Group | Value | 95% CI |
|---|---|---|
| HBO Feasibility | 5 | |
| Historic Controls | 6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| HBO Feasibility | 26.5 | ± 3.4 |
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 a
| Group | Value | 95% CI |
|---|---|---|
| HBO Feasibility | 66.8 | ± 24.6 |
Time frame: Adverse events (AE) for the HBO Feasibility arm will be collected during the period from the initiation of the study procedures until the date of documented death, withdrawal of consent, or the end of the study, whichever occurs first. Collection could span approximately 5 years. Adverse events were not collected for the historic controls.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | HBO Feasibility | Historic Controls |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Cognitive Disturbance | Nervous system disorders | — | — |
| Seizure | Nervous system disorders | — | — |
| Memory Impairment | Nervous system disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Concentration impairment | Nervous system disorders | — | — |
| Dysphasia | Nervous system disorders | — | — |
| Dysarthria | Nervous system disorders | — | — |
| Ataxia | Nervous system disorders | — | — |
| Intercranial hemorrhage | Nervous system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Facial muscle weakness | Nervous system disorders | — | — |
| Tremor | Nervous system disorders | — | — |
| Presyncope | Nervous system disorders | — | — |
| Dysarthria | Nervous system disorders | — | — |
Data from ClinicalTrials.gov NCT01850563 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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