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Trial record 14 of 1104 for:    pharmacogenomics OR pharmacogenetics

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

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ClinicalTrials.gov Identifier: NCT02542397
Recruitment Status : Terminated (Early study closure due to limited internal resources to continue enrollment.)
First Posted : September 7, 2015
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jai Patel, Atrium Health

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.

Condition or disease Intervention/treatment Phase
Malignant Tumor of Ill-defined Site Genetic: Pharmacogenomic Testing Phase 2

Detailed Description:

All subjects will be assessed and prescribed a pain regimen as part of standard practice at the initial visit. Subjects will provide a buccal swab for pharmacogenomic testing and will be discharged on their initial pain regimen.

After the initial visit, subjects will be asked to rate their daily pain on a scale of 0-10. A coordinator will follow up with the subject within 7 days (Assessment #1). Subjects will be asked to report information about their pain scores, pain medication use, and caffeine intake, in addition to any bothersome symptoms. Subjects who continue to have "uncontrolled pain", are experiencing bothersome symptoms, and/or requests for a drug/dose modification will have his/her drug/dose modified using the pharmacogenomic test results. If the subject has had significant pain improvement, stable mild pain and/or is satisfied with their level of pain at the assessment (regardless of pain score), he/she will be recommended to continue the current drug/dose and return to clinic on day 30 for the final follow-up. Subjects will be told to call if their pain becomes intolerable or if they experience bothersome symptoms after Assessment #1 for further drug/dose modification if needed prior to day 30.

The coordinator will follow up with the subjects receiving a drug/dose modification after another 7 days (Assessment #2). Subjects who have now had significant pain improvement, stable mild pain, and/or are satisfied with their level pain at the assessment (regardless of pain score) will continue on the same regimen. If the subjects' pain is still "uncontrolled", they are experiencing bothersome symptoms, and/or they request a drug/dose modification, their drug/dose will be modified accordingly. Subjects will be told to call if needed, otherwise they will be seen in clinic on day 30 (Final Assessment).

If the subject experiences intolerable pain prior to any scheduled assessment, the subject will call for appropriate drug/dose modification.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pharmacogenomic testing
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Pilot Study of Pain Management in Oncology Outpatients
Study Start Date : September 2015
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pharmacogenomic Testing
Pharmacogenomic test results to guide drug/dose modifications
Genetic: Pharmacogenomic Testing
Pharmacogenomic test results to guide drug/dose modifications




Primary Outcome Measures :
  1. Significant pain improvement as measured using the Edmonton Symptom Assessment Scale from baseline visit to day 30 [ Time Frame: 30 days post enrollment ]
    Percentage of subjects achieving significant pain improvement over a one month period (defined as a ≥ 2 point decrease from baseline pain score on an 11-point scale [0-10]) in oncology outpatients receiving pharmacogenomic testing.


Secondary Outcome Measures :
  1. Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 30 days post enrollment ]
    Opioid-related adverse events stratified by pain response and pharmacogenomic test results

  2. Morphine equivalent daily doses (MEDD) in milligrams [ Time Frame: 30 days post enrollment ]
    MEDD stratified by pain response and pharmacogenomic test results

  3. Frequency of actionable genotypes, defined as the presence of any mutation(s) that is (are) used to guide a drug/dose modification [ Time Frame: 30 days post enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542397


Locations
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United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Jai Patel
Investigators
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Principal Investigator: Jai Patel, PharmD Levine Cancer Institute

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Responsible Party: Jai Patel, Chief, Pharmacology Research, Atrium Health
ClinicalTrials.gov Identifier: NCT02542397     History of Changes
Other Study ID Numbers: LCI-NOS-PAIN-001
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Neoplasms