Approach reduces pain, opioid demand among people with pancreatic cancer
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The delivery of transvascular energy reduced pain and improved quality of life within 7 days among patients with pancreatic cancer, according to a topline data announcement.
The approach also reduced demand for opioids.
The preliminary findings are “incredibly encouraging,” Brad Hauser, CEO of Autonomix Medical Inc., said in a company press release.
“These data provide a strong indication that our technology has the potential to revolutionize the treatment paradigm for pancreatic cancer pain,” Hauser said.
More than 80% of people with pancreatic cancer report moderate to severe pain, according to the release.
Opioids are a standard pain-reduction strategy, but patients often still present to the ED for breakthrough pain, sometimes necessitating treatment dosing interruptions.
Autonomix developed technology through which a catheter-based microchip sensing array antenna detects and differentiates neural signals, according to the press release. Radiofrequency ablation technology then kills targeted nerves, with the goal of reducing pain.
Autonomix conducted a proof-of concept clinical trial in which they enrolled 15 patients who reported severe abdominal pain due to unresectable pancreatic cancer. All participants had life expectancy of 3 months or less.
The success rate of ablating relevant nerves to mitigate pain served as the primary objective. Secondary objectives included incidence of device- and procedure-related adverse events up to 4 to 6 weeks after, as well as estimated changes in pain levels and quality of life from before the procedure to after.
One patient could not receive treatment due to stenosis severity.
The modified intent-to-treat population included 14 treated patients (femoral access, n = 11; brachial access, n = 3), with results based on outcomes 7 days after the procedure.
Eleven (79%) of the 14 patients responded to treatment based on reduction of pain on the 10-point Visual Analogue Scale. Researchers reported a mean reduction of 4.96 points at 7 days after treatment. Scores declined from 7.82 at baseline — a number that falls in a range defined as “very intense" to "utterly horrible" — to 2.86, a number that falls in a range defined as “discomforting” to “tolerable.”
All 11 patients treated with femoral access responded, whereas none of the patients treated with brachial access exhibited improvement in pain scores.
No patient who responded to treatment needed opioids after their 24-hour post-procedure follow-up visit, and results showed a reduction in opioid demand through 7 days after the procedure.
Patients who responded to treatment also reported a 66% mean improvement in overall health status at 7 days.
Additional evaluations of patients who underwent successful procedures will be conducted 4 to 6 weeks after, as well as 3 months after.
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