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Pharmacogenomics
Genetic Testing for Pain Relief in Cancer (C-PAIN Trial)
N/A
Recruiting
Led By Peter H O'Donnell
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be at least 18 years of age
Be older than 18 years old
Must not have
Chronic kidney disease, as defined by Glomerular filtration rate (GFR) < 30/mL/min/1.73m2
Subjects who are currently undergoing palliative radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how preemptive genetic testing can help doctors choose the right dose of pain medication for cancer patients.
Who is the study for?
This trial is for adult cancer patients at the University of Chicago Medical Center who may need opioid pain relief soon. It's not for those currently on opioids, pregnant, in other PGx studies, with liver or severe kidney issues, undergoing certain treatments like palliative radiation or organ transplants, or with blood cancers.
What is being tested?
The study tests how preemptive pharmacogenomic (PGx) testing can influence opioid selection and dosing decisions to manage pain in cancer patients. Participants are randomly assigned to receive treatment based on their genetic makeup.
What are the potential side effects?
While specific side effects aren't listed here, typical risks might include reactions related to changes in opioid medication due to PGx results such as nausea, constipation, drowsiness or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is very low.
Select...
I am currently receiving radiation to ease symptoms.
Select...
I have or had leukemia.
Select...
I have taken opioids in the last 30 days or am currently taking them.
Select...
My liver is not functioning properly according to recent tests.
Select...
I am able to understand and agree to participate in the study.
Select...
I am being considered for, or have had, a bone marrow, liver, or kidney transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 45 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain control.
Secondary study objectives
Composite Pain Intensity
Cumulative Morphine
Hospitalization or Emergency Visit for Pain Control
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PGx ArmExperimental Treatment1 Intervention
PGX information is provided to clinicals to inform opioid dosing and selection.
Group II: Control ArmActive Control1 Intervention
No PGX information provided opioid dosing and selection is according to standard of care.
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
839,334 Total Patients Enrolled
National Human Genome Research Institute (NHGRI)NIH
270 Previous Clinical Trials
293,269 Total Patients Enrolled
Peter H O'DonnellPrincipal InvestigatorUniversity of Chicago