LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Study of Pain Management in Oncology Outpatients

NCT02542397 | Terminated Phase 2 Results DMC

• 1 other identifier: LCI-NOS-PAIN-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

About half of all cancer patients seen in oncology clinics have pain at initial assessment; pain relief within a one-month period is seen in approximately one third of these patients and pain worsening in about one fifth. Risk factors for under-treatment of cancer pain include age older than 65 years, minority status, and inadequate pain assessment practices. There is a need for better methods of opioid drug/dose selection and identification of risk factors for worsening pain. Pharmacogenomic approaches offer insight into the genetic variables that impact the pharmacokinetic and pharmacodynamic behavior of opioids. Translating pharmacogenomic results into actionable prescribing decisions may ultimately enable a personalized approach to pain management, increasing the chance of significant pain improvement. Cancer outpatients with uncontrolled malignant pain will be offered a pharmacogenomic test through participation in the study. The results of this test will be used to modify their pain regimen, if applicable.

Conditions

Malignant Tumor of Ill-defined Site

Outcome Measures

Primary Outcomes (1)

• Rate of Pain Improvement as Measured Using the Edmonton Symptom Assessment Scale (ESAS) From Baseline Assessment (Day 0) to Final Assessment on Day 30 +/- 7

  Proportion of subjects achieving significant pain improvement over a one month period (30 days +/- 7) (defined as a ≥ 2 point decrease from baseline pain score on an 11-point scale \[0-10\]) in oncology outpatients receiving pharmacogenomic testing.

  Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))

Secondary Outcomes (2)

• Morphine Equivalent Daily Doses (MEDD) in Milligrams

  Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))

• Percentage of Subjects With an Actionable Genotype, Defined as the Presence of Any Mutation(s) That is (Are) Used to Guide a Drug/Dose Modification

  Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))

Study Arms (1)

Pharmacogenomic Testing

EXPERIMENTAL

Pharmacogenomic test results to guide drug/dose modifications

Genetic: Pharmacogenomic Testing

Interventions

Pharmacogenomic Testing GENETIC

Pharmacogenomic test results to guide drug/dose modifications

Pharmacogenomic Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of uncontrolled malignant pain (score of greater than or equal to 2 on an 11 point scale \[0-10\]) as diagnosed and assessed by the Investigator, using the Edmonton Symptom Assessment Scale (ESAS).
• Documentation of any stage of cancer of any tumor location (solid or hematological).
• At least 18 years of age.
• Either nociceptive or neuropathic pain.
• Able to understand and be willing to sign the study consent form.

You may not qualify if:

• Inpatient service at baseline visit.
• Significant dysphagia and inability to swallow oral medications as determined by the Investigator.
• Active or recent (within one year) drug and/or alcohol abuse as determined by the Investigator.
• Significant baseline cognitive impairment, as determined by the Investigator. Known (anaphylactic) hypersensitivity to any opioid.
• Severe oral mucositis that would impair proper buccal testing as determined by the Investigator.
• Receiving concurrent rehabilitation medicine care, nociception modulation (e.g., electrical stimulation), use of modalities with physiologic effects that indirectly influence nociception (e.g., light, laser therapy), or any other non-pharmacologic approaches to pain management other than exercise, rest, ice, compression, and elevation (RICE).
• Presence of major psychiatric disorders as determined by the Investigator.
• Receiving active treatment or prophylaxis for epilepsy.
• Unable or unwilling to sign the study consent form.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Related Publications (1)

• Patel JN, Boselli D, Symanowski J, Wodarski S, Turner S, Slaughter C, Myers M, Edwards R, Susi B, Greiner R, Edelen C. Pilot study of multi-gene pharmacogenetic testing for pain management in oncology palliative medicine. Pharmacogenomics. 2021 Aug;22(12):737-748. doi: 10.2217/pgs-2021-0037. Epub 2021 Aug 20.

  PMID: 34414777 DERIVED

MeSH Terms

Interventions

Pharmacogenomic Testing

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Limitations and Caveats

Early study closure due to limited internal resources to continue enrollment.

Results Point of Contact

• Title: Danielle M Boselli
• Organization: Atrium Health/Levine Cancer Institute, Department of Cancer Biostatistics

Danielle.Boselli@AtriumHealth.org

12017903385

Study Officials

• Jai Patel, PharmD

  Atrium Health Levine Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled subjects all receive pharmacogenomic testing with the intention of guiding pain management. This single-arm trial is testing against a published historical control.

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 7, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: November 3, 2022
• Results First Posted: February 2, 2021

Record last verified: 2021-03

Locations

US (1)