Genetic Testing for Pain Relief in Cancer

(C-PAIN Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Peter O'Donnell, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Chicago

Must not be taking: Opioids

Disqualifiers: Blood cancer, Chronic kidney disease, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be taking opioids at the time of enrollment or within the past 30 days.

What data supports the effectiveness of the treatment Pharmacogenomic (PGx) Testing for pain relief in cancer?

Research shows that pharmacogenomic (PGx) testing can help tailor pain medication choices and dosages based on a person's genetic makeup, potentially improving pain relief and reducing side effects. This approach has been increasingly used in areas like oncology to enhance treatment effectiveness and safety. ^{1 2 3 4 5}

Is genetic testing for pain relief in cancer safe for humans?

Pharmacogenomic (PGx) testing, which includes genetic testing for pain management, is generally considered safe and helps doctors choose the right medications and doses to reduce side effects. It has been used in various medical settings, including for children with complex conditions, to minimize adverse drug reactions. ^{4 5 6 7 8}

How is the treatment Pharmacogenomic Testing unique for pain relief in cancer?

Pharmacogenomic Testing is unique because it uses a person's genetic information to tailor pain medication choices and dosages, potentially improving effectiveness and reducing side effects compared to standard treatments that do not consider genetic factors. ^{1 2 4 5 6}

Research Team

Peter O'Donnell, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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.

Inclusion Criteria

I am being treated at the University of Chicago Medical Center and expect to need pain medication soon.

I am 18 years old or older.

Exclusion Criteria

I am currently receiving radiation to ease symptoms.

Subjects who are known to be pregnant at the time of enrollment

Subjects who are enrolled in other Pharmacogenomic (PGx) studies

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive preemptive pharmacogenomic (PGx) testing to inform opioid dosing and selection

6 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Pharmacogenomic (PGx) Testing (Pharmacogenomics)

Trial Overview 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.

Participant Groups

Group I: PGx Arm Experimental Treatment 1 Intervention

PGX information is provided to clinicals to inform opioid dosing and selection.

Group II: Control Arm Active Control 1 Intervention

No PGX information provided opioid dosing and selection is according to standard of care.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Chicago Medicine Comprehensive Cancer Center Chicago, IL

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1086

Patients Recruited

844,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Patients Recruited

299,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenomics in clinical trials: an overview. Nogueiras-Álvarez, R.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Pain Management with Pharmacogenomics: A General Introduction. Schuh, MJ., Randles, H., Crosby, S.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the need for pharmacogenomics testing among physicians in the West Bank of Palestine. Jarrar, Y., Musleh, R., Hamdan, A., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating pharmacogenomics into precision pain management. Bates, J., Fudin, J., Patel, JN.[2022]

Pharmacogenomic (PGx) testing is increasingly used in psychiatry to help guide medication decisions, potentially improving treatment response and identifying patients at risk for side effects.

Despite its benefits, the implementation of PGx testing in clinical practice faces challenges, and more research is needed to determine the best ways to integrate it into psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utilization of Pharmacogenetics in Psychiatry - Perspectives of Pharmacists, Genetic Counselors, Implementation Science, Clinicians, and Industry. Brown, L., Eum, S., Haga, SB., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Implementation of Pharmacogenomic Testing in a Pediatric Tertiary Care Setting. Cohn, I., Manshaei, R., Liston, E., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study for Return of Individual Pharmacogenomic Results to Population-Based Cohort Study Participants. Ohneda, K., Hiratsuka, M., Kawame, H., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenetic Testing: A Tool for Personalized Drug Therapy Optimization. Malsagova, KA., Butkova, TV., Kopylov, AT., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacogenomics in clinical trials: an overview. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Improving Pain Management with Pharmacogenomics: A General Introduction. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of the need for pharmacogenomics testing among physicians in the West Bank of Palestine. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Integrating pharmacogenomics into precision pain management. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Clinical Utilization of Pharmacogenetics in Psychiatry - Perspectives of Pharmacists, Genetic Counselors, Implementation Science, Clinicians, and Industry. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Assessment of the Implementation of Pharmacogenomic Testing in a Pediatric Tertiary Care Setting. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

A Pilot Study for Return of Individual Pharmacogenomic Results to Population-Based Cohort Study Participants. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacogenetic Testing: A Tool for Personalized Drug Therapy Optimization. [2020]