ESMO: Combination therapy reduced agitated delirium in patients with advanced cancers study led by MD Anderson Cancer Center

Treatment with a combination of haloperidol and lorazepam reduced symptoms of agitated delirium, a common end-of-life condition for patients with advanced cancers, compared with haloperidol alone, according to a new study led by researchers at The University of Texas MD Anderson Cancer Center. The findings were presented at the 2024 European Society for Medical Oncology (ESMO) Congress.

Agitated delirium occurs when a patient’s brain function begins to deteriorate as their cancer advances; at this time, many patients begin behaving aggressively or abnormally. Although the use of medication in this setting has been debated, these results suggest tailored combination treatments can significantly improve symptoms for patients at the end of life.

“Advanced delirium is common and highly distressing in many patients with advanced cancers in palliative care units, but we’ve had limited evidence on the use and effectiveness of treatment for this condition.

The RECORD trial offers valuable data and insights that support the use of therapy in the palliative care setting in order to provide patients with greater comfort,” – said lead investigator David Hui, Professor of Palliative, Rehabilitation and Integrative Medicine.

Patients that received the combination of haloperidol and lorazepam experienced a significant decrease in agitated delirium when measured at 24 hours with a standard scoring tool. In that same time frame, this group needed no more than two additional rescue doses, or additional medication provided as needed.

Researchers also observed a significant decrease in agitated delirium in patients treated with lorazepam alone, but these patients required more rescue doses. The placebo group saw very little reduction in delirium and, in some scenarios, patients needed as many as five additional rescue doses.

The multi-center trial evaluated treatment in 75 adult patients across multiple cancer types. Patients received blinded treatment with the combination therapy, lorazepam only or placebo intravenously every four hours. The adverse events observed on the study were expected and consistent with the end-of-life process.

“By proactively personalizing treatment of this distressing symptom, we are providing caregivers, families and patients an opportunity for meaningful connection in the time they have remaining,” – Hui said.

The trial is funded by the National Cancer Institute (R01CA214960). Hui was a consultant for Eton Pharmaceuticals.

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