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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)
Must not have
History of neuroleptic malignant syndrome or active seizure disorder (with seizure episode within the past week)
History of Parkinson's disease or Alzheimer's dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time 0 or baseline and 30 minutes later.
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group

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.
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.
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 below
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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.
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I have been restless or agitated recently.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a seizure in the last week or a history of neuroleptic malignant syndrome.
Select...
I have been diagnosed with Parkinson's disease or Alzheimer's.
Select...
I have a history of myasthenia gravis or acute narrow angle glaucoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time 0 or baseline and 30 minutes later.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time 0 or baseline and 30 minutes later. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Richmond Agitation Sedation Score (RASS) (0-24h)
Secondary study objectives
Change in Delirium Experience Questionnaire
Change in RASS Score (0-30 Minutes)
Edmonton Expression Assessment System, ESAS
+7 more

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
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%
Blurred vision
2%
Hypothyroidism
2%
Urticaria
2%
Hemorrhoids
2%
Acute kidney injury
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

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
600 Previous Clinical Trials
10,377,509 Total Patients Enrolled
2 Trials studying Delirium
479 Patients Enrolled for Delirium
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,175 Total Patients Enrolled
6 Trials studying Delirium
539 Patients Enrolled for Delirium
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,931 Total Patients Enrolled
5 Trials studying Delirium
1,339 Patients Enrolled for Delirium
~8 spots leftby Nov 2025
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