Genetic Testing for Pain Relief in Cancer

(C-PAIN Trial)

Overseen By Clinical Trials Intake

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Opioids

Disqualifiers: Blood cancer, Chronic kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

800 Participants Needed

Trial Summary

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}

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.

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.

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

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

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.

Pharmacogenomic (PGx) Testing is already approved in United States, European Union for the following indications:

Approved in United States as Pharmacogenomic Testing for:

• Guiding opioid selection and dosing in cancer pain management

Approved in European Union as PGx Testing for:

• Personalizing pain management based on genetic variations

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Recruited

299,000+

Findings from Research

The inclusion of pharmacogenetics and pharmacogenomics (PGx) in clinical trials has been increasing since the 2000s, particularly in Oncology (28.43%) and Mental Health (10.66%), highlighting its growing importance in personalized medicine.

Key genes studied in these trials include CYP2D6, CYP2C9, and CYP2C19, which are crucial for understanding drug metabolism and improving treatment safety and efficacy, emphasizing the need for training in PGx for researchers and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Pharmacogenomic (PGx) testing can significantly enhance pain management by guiding medication choices, optimizing dosages, and reducing the risk of adverse drug reactions, ultimately leading to better therapeutic outcomes for patients.

Understanding the genetic factors that influence drug response, such as variations in cytochrome P450 enzymes and other relevant genes, is crucial for healthcare providers to effectively implement PGx testing in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

A survey of 381 physicians in the West Bank of Palestine revealed that 81.1% had low exposure to pharmacogenomics (PGx) education, indicating a significant gap in their training regarding personalized medicine.

Over 90% of the physicians agreed that PGx should be included in medical school curricula, and 58.5% recognized its relevance to their practice, highlighting a strong demand for PGx education and testing implementation in clinical settings.

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]

Pharmacogenomics (PGx) testing can enhance pain management by allowing for more precise selection and dosing of analgesics based on individual genetic responses, which is crucial given the variability in how patients respond to pain medications.

The Clinical Pharmacogenetics Implementation Consortium (CPIC) provides guidelines that can help healthcare providers apply PGx data in clinical practice, particularly for patients with cancer, to improve the efficacy and safety of pain pharmacotherapy.

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]

In a study of 172 children at The Hospital for Sick Children, pharmacogenomic (PGx) testing revealed that 36.8% of patients in the point-of-care cohort had genetic profiles that required changes to their standard medication dosages, highlighting the importance of personalized medicine.

In the preemptive cohort, 80% of children were advised to follow nonstandard treatment regimens based on whole-genome sequencing, demonstrating the potential of PGx testing to optimize drug therapy and reduce adverse reactions in pediatric patients.

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]

In a study involving 161 participants, returning pharmacogenomic (PGx) testing results for actionable genes led to over 80% of participants feeling satisfied and knowledgeable about how this information could benefit their future medication prescriptions.

Despite the overall positive reception, some participants found the PGx concepts challenging to understand, indicating a preference for in-person discussions when receiving their results, which highlights the need for effective communication in genetic testing.

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]

Pharmacogenomics (PGx) testing helps physicians tailor drug therapies based on a patient's genetic background, potentially improving treatment outcomes for those who do not respond to standard therapies.

The effectiveness of PGx testing relies on physicians' understanding of genetic results and their implications for personalized treatment, highlighting the need for standardized interpretation to ensure patient safety and data security.

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]