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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if genetic testing can help doctors select the right opioid pain medications for cancer patients, enhancing pain management effectiveness. Participants will be divided into two groups: one will use genetic test results to guide treatment, while the other will receive standard care without these results. This study targets cancer patients at the University of Chicago who anticipate needing opioid pain relief soon and are not currently taking opioids. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance personalized pain management for future 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 prior data suggests that pharmacogenomic testing is safe for pain management in cancer patients?

Research has shown that pharmacogenomic (PGx) testing is generally safe for people. Studies have found that PGx testing helps determine how individuals might respond to certain medications, predicting who might experience side effects or benefit more from a drug.

In one study, patients who used PGx testing reported a better quality of life and less pain. Another study demonstrated that PGx testing can help doctors choose the right medication doses, reducing side effects. The testing itself doesn't involve taking any drugs, so it isn't expected to cause harm. Instead, it provides information to make medication use safer.

Overall, PGx testing is well-tolerated and can improve treatment choices by reducing the risk of negative reactions to medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pharmacogenomic (PGx) testing for pain relief in cancer patients because it offers a personalized approach to opioid prescribing. Unlike the standard practice where opioids are prescribed according to a general guideline, PGx testing provides clinicians with genetic information that can guide the selection and dosing of opioids tailored to each patient's genetic makeup. This personalized method has the potential to enhance pain management, reduce side effects, and minimize the risk of opioid misuse, making it a promising advancement over current standard treatments.

What evidence suggests that pharmacogenomic testing is effective for pain management in cancer patients?

Research has shown that testing a person's genes can help customize pain management. In this trial, participants in the PGx Arm will undergo pharmacogenomic (PGx) testing, which examines genetic differences affecting medication responses, such as opioids used for pain relief in cancer patients. With this genetic testing, doctors can better select the appropriate type and dose of opioid for each patient, potentially improving pain control. Over 90% of people have genetic differences that could alter their reaction to medications, making this testing a promising tool for personalized care. This approach aims to enhance pain management effectiveness while reducing side effects. ^{4 5 6 7 8}

Who Is on the Research Team?

Peter O'Donnell, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10020807/

Evidence Regarding Pharmacogenetics in Pain Management ... Patients are more likely to be prescribed opioids if they have cancer or have survived cancer, compared to those without a history of cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1875459715300278

Pharmacogenomics for personalized pain medicine This review discusses the use of drugs for pain management in the context of the recent pharmacogenomic studies on ADRs and drug efficacy.

3. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.2875

CYP2D6‐guided opioid therapy for adults with cancer pain: A ... Our study revealed high acceptance of pharmacogenetic testing as part of a clinical trial among patients with cancer pain. However, provider ...

4. wolterskluwer.com wolterskluwer.com/en/expert-insights/pharmacogenomics-effect-of-gene-variability-on-pain-management

Pharmacogenomics: Effect of Gene Variability on Pain ... It is estimated greater than 90% of the population has some genetic variation which could change how a patient responds to one or more medication.

5. link.springer.com link.springer.com/article/10.1007/s40122-017-0069-2

Genetic Testing for Opioid Pain Management: A Primer This paper serves as a primer for PCPs to enhance their understanding of pharmacogenetics, with a focus on opioid pain medications.

6. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2019.37.31_suppl.117

Pharmacogenetic (PGx) guided cancer pain management ... Results: Of 75 undergoing PGx testing, 52 were evaluable for the primary endpoint (54% female, 81% white, 17% black, median age 63, 75% stage 3 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12255864/

Association of Pharmacogenotyping and Patient-Reported ... Conclusions: HRQoL and pain intensity significantly improved after PGx testing, with potentially clinically relevant results in the PGx-guided ...

8. xmed.jmir.org xmed.jmir.org/2022/2/e32902

Effects of Pharmacogenomic Testing in Clinical Pain ... This study demonstrates the predictive value of PGx testing combined with a customized informational report to help improve clinical outcomes, ...