Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer
NCT ID: NCT05830279
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2023-05-01
2026-04-30
Brief Summary
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The investigators hypothesize that the pharmacogenetic variation and DDI, if applicable, determine steady state drug concentration and therapeutic response or toxicity of the investigated antidepressant, pain or antiemetic treatments at baseline, while there is a clinically significant reduction or absence of the effect 6 months after the PM clinic recommendations to referring physicians and patients.
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Detailed Description
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Patients will be assigned to one or more cohorts, as appropriate, at the screening visit: Cohort 1 (n=200) if prescribed antidepressants including the selective serotonin reuptake inhibitors (SSRI) citalopram or escitalopram, or the selective norepinephrine reuptake inhibitors (SNRI) venlafaxine or desvenlafaxine; Cohort 2 (n=200) if prescribed opioid pain medications including codeine, oxycodone, hydrocodone, or tramadol; and/or Cohort 3 (N=200) if prescribed the antiemetic agent ondansetron.
Each patient will participate in a PM clinic screening visit. Eligible patients will attend three subsequent study visits at 0.5, 4 (virtual), and 7 months after screening. At each PM clinic visit, clinical information and a venous blood sample will be collected. Patients will also complete the ESAS survey and validated scores/ surveys to evaluate treatment effectiveness.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Anti-depressants
Patients who have been prescribed either 1) the selective serotonin reuptake inhibitors (SSRI) citalopram or escitalopram, or 2) the selective norepinephrine reuptake inhibitors (SNRI) venlafaxine or desvenlafaxine
Pharmacogenetic testing
Genotyping for CYP2D6 and CYP2C19
Drug-Drug interaction analysis
Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.
Opioid pain medications
Patients who have been prescribed opioid pain medications including codeine, oxycodone, hydrocodone, or tramadol.
Pharmacogenetic testing
Genotyping for CYP2D6 and CYP2C19
Drug-Drug interaction analysis
Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.
Anti-metics
Patients who have been prescribed the antiemetic agent ondansetron
Pharmacogenetic testing
Genotyping for CYP2D6 and CYP2C19
Drug-Drug interaction analysis
Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.
Interventions
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Pharmacogenetic testing
Genotyping for CYP2D6 and CYP2C19
Drug-Drug interaction analysis
Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.
Eligibility Criteria
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Inclusion Criteria
* Prescribed a chemotherapy medication
* Currently taking one or more study medications (citalopram, escitalopram, venlafaxine, desvenlafaxine, codeine, oxycodone, hydrocodone, tramadol or ondansetron)
Exclusion Criteria
* Patients receiving palliative care
* Patients taking anti-depressants for reason other than depression or anxiety, i.e. hot flash (Only applies to antidepressant cohort)
* Patients with preexisting major depressive disorder prior to cancer diagnosis (Only applies to antidepressant cohort)
18 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Richard Kim
Professor
Principal Investigators
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Richard Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Western University, Canada
Locations
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Lawson Health Research Institute
London, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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11642
Identifier Type: -
Identifier Source: org_study_id
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