This phase II/III trial tests whether haloperidol, chlorpromazine, and valproate in combination with other standard non-drug treatment works to improve symptoms of agitated delirium (confusion) in patients with advanced cancer (cancer that has spread to other places in the body). Giving haloperidol, chlorpromazine, valproate in combination with other standard non-drug treatment may help to control symptoms of delirium and lower the level of distress related to delirium.
Additional locations may be listed on ClinicalTrials.gov for NCT05431595.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: David Hui
Phone: 713-792-6085
PRIMARY OBJECTIVE:
I. Compare the effect of scheduled haloperidol, chlorpromazine, valproic acid (valproate) and placebo (non-pharmacological interventions alone) on the frequency of breakthrough restlessness over 72 hours in patients with agitated delirium seen by the palliative care or psychiatry consultation team.
SECONDARY OBJECTIVES:
I. Compare the effects of scheduled haloperidol, chlorpromazine, valproate and placebo on Richmond Agitation Sedation Scale-Palliative Care (RASS-PAL), need for dose escalation, perceived comfort by caregivers and bedside nurses, delirium severity (Memorial Delirium Assessment Scale), delirium-related distress in caregivers and nurses (Delirium Experience Questionnaire), delirium recall in patients (Delirium Recall Questionnaire), symptom expression (Edmonton Symptom Assessment Scale), adverse effects, and survival.
II. Estimate the efficacy of non-pharmacologic interventions alone on breakthrough restlessness.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP I: Patients receive haloperidol intravenously (IV) every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
GROUP II: Patients receive chlorpromazine IV every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
GROUP III: Patients receive valproic acid IV every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
GROUP IV: Patients receive placebo IV over 3-5 minutes every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Trial PhasePhase II/III
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorDavid Hui
