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Antipsychotic
Haloperidol +/- Chlorpromazine for Delirium in Cancer Patients
Phase 2 & 3
Waitlist Available
Led By David Hui
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admitted to the acute palliative care unit
Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time 0 or baseline and 30 minutes later.
Awards & highlights
Study Summary
This trial will test how well haloperidol with or without chlorpromazine works to treat delirium in cancer patients.
Who is the study for?
This trial is for adults with advanced cancer experiencing delirium, who are admitted to the acute palliative care unit. They must have a diagnosis of hyperactive or mixed delirium and be on haloperidol treatment. Excluded are those with neuroleptic malignant syndrome, seizure disorders, Parkinson's disease, Alzheimer's dementia, hypersensitivity to the drugs being tested, myasthenia gravis, glaucoma or a prolonged QTc interval.Check my eligibility
What is being tested?
The study is testing whether adding chlorpromazine to haloperidol is more effective in treating delirium symptoms in patients with advanced cancer than using haloperidol alone. It's a randomized trial where patients will either receive both medications or just haloperidol while their quality of life and symptom changes are monitored.See study design
What are the potential side effects?
Possible side effects include drowsiness, dry mouth, blurred vision, constipation and difficulty urinating due to chlorpromazine; and restlessness or stiffness from haloperidol. Both drugs can also cause low blood pressure when standing up.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently admitted to a palliative care unit.
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My cancer is advanced and cannot be cured with surgery or radiation alone.
Select...
I have been restless or agitated recently.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time 0 or baseline and 30 minutes later.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time 0 or baseline and 30 minutes later.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Richmond Agitation Sedation Score (RASS) (0-24h)
Secondary outcome measures
Change in Delirium Experience Questionnaire
Change in RASS Score (0-30 Minutes)
Edmonton Expression Assessment System, ESAS
+7 moreSide effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Acute kidney injury
2%
Blurred vision
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group III (haloperidol, chlorpromazine)Experimental Treatment4 Interventions
Patients receive haloperidol and chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Group II: Group II (chlorpromazine)Experimental Treatment3 Interventions
Patients receive chlorpromazine IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Group III: Group I (haloperidol)Experimental Treatment3 Interventions
Patients receive haloperidol IV over 3-15 minutes every 4 hours in the absence of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorpromazine
FDA approved
Haloperidol
FDA approved
Find a Location
Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
579 Previous Clinical Trials
10,376,312 Total Patients Enrolled
2 Trials studying Delirium
479 Patients Enrolled for Delirium
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,732 Total Patients Enrolled
6 Trials studying Delirium
678 Patients Enrolled for Delirium
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,597 Total Patients Enrolled
5 Trials studying Delirium
1,298 Patients Enrolled for Delirium
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Why did researchers design this experiment in this way?
"The primary objective of this clinical trial is to monitor the Richmond Agitation Sedation Scale (RASS) over a period of time 0 or Baseline and 24 hours after study medication administration. Secondary outcomes include the After Death questionnaire, which is used to examine the quality of death, and the Perceived Comfort and agitation levels, which are used to assess whether study medications impact patient comfort and agitation levels. Additionally, the Pattern of Medication Use will be monitored in order to track neuroleptic and benzodiazepine use during the first 24 hours after study medication administration."
Answered by AI
How many test subjects are involved in this clinical trial?
"Although this study is no longer recruiting patients, it was active from June 5th, 2017 to October 20th, 2020. If you are interested in similar studies, 3564 trials for delirium and 11 Quality-of-Life Assessments are still looking for participants."
Answered by AI
Are there any open spots left for participants in this clinical trial?
"This particular trial is no longer enrolling patients. However, if you are interested in other similar studies, there are currently 3564 clinical trials actively recruiting participants with delirium and 11 studies for Quality-of-Life Assessment actively searching for participants."
Answered by AI
What types of conditions generally prompt a Quality-of-Life Assessment?
"Quality-of-Life Assessment is a tool that not only can be used to combat short term hyperactivity, but also conditions like nausea, severe hyperactivity, and aggressive reaction."
Answered by AI
Is this the first time Quality-of-Life Assessment has been looked at in a clinical setting?
"There are currently 11 ongoing studies regarding Quality-of-Life Assessment, with 3 of those trials in their last stage. Although a few of the investigations into Quality-of-Life Assessment are based in Saint Joseph, Michigan, there are a total of 55 locations conducting these sorts of trials."
Answered by AI
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