Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer

Evaluating the Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer Patients: A Prospective Longitudinal Trial

A prospective longitudinal cohort study that will assess the effect of a Personalized Medicine (PM) clinic recommendations on pharmacogenetic variation and/or interacting drugs on plasma drug exposure, effectiveness or toxicity of commonly used antidepressant, pain, and antiemetic medications in cancer patients. Such recommendations will entail genotype-guided treatment suggestions while also considering potential DDI, and will be provided to patients during their clinic visit, and referring physicians thereafter. Drug concentration and therapeutic effectiveness will be assessed before (baseline) and 6 months after recommendations have been provided. To assess effectiveness, patient-reported outcomes will be evaluated using validated scales for symptoms of depression, pain and chemotherapy-induced nausea/ vomiting

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Pain; Nausea With Vomiting Chemotherapy-Induced; Depression, Reactive
• Intervention / Treatment: Genetic: Pharmacogenetic testing; Other: Drug-Drug interaction analysis

Detailed Description

This prospective longitudinal study will consist of three cohorts of adult cancer patients routinely referred to the PM clinic for genotype-guided chemotherapy including 5-FU or tamoxifen that are also taking antidepressant, analgesic and/or antiemetic medications.

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Richard Kim, MD; Phone Number: 33553 519-685-8500; Email: richard.kim@lhsc.on.ca
• Study Contact Backup: Name: Samantha Medwid, PhD; Phone Number: 32099 519-685-8500; Email: samantha.medwid@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6C 2R5
      • Recruiting
      • Lawson Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients taking selective medications for treatment of chemotherapy side effects, pain, depression and nausea.

Description

Inclusion Criteria:

• Age 18 years or older
• Prescribed a chemotherapy medication
• Currently taking one or more study medications (citalopram, escitalopram, venlafaxine, desvenlafaxine, codeine, oxycodone, hydrocodone, tramadol or ondansetron)

Exclusion Criteria:

• Patients who are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients
• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Genetic: Pharmacogenetic testing; Genotyping for CYP2D6 and CYP2C19; Other: 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.	Genetic: Pharmacogenetic testing; Genotyping for CYP2D6 and CYP2C19; Other: 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	Genetic: Pharmacogenetic testing; Genotyping for CYP2D6 and CYP2C19; Other: Drug-Drug interaction analysis; Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug level measurements	Steady-state drug plasma concentration of the antidepressant (Cohort 1), pain (Cohort 2) or antiemetic medication (Cohort 3) at follow-up visit 2 at 6 months compared to the baseline visit as assessed by single time points	Baseline visit to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MASCC Antiemesis Tool (MAT) survey	Difference in MAT survey results in each cohort at the follow up visits (3 and 6 months) compared to baseline visit	Baseline visit to 6 months
Edmonton Symptom Assessment Scale (ESAS) Survey	Difference in ESAS survey results in each cohort at the follow up visits (3 and 6 months) compared to baseline visit. 10 questions, scale for each question between 0-9, higher score is associated with worse outcomes.	Baseline visit to 6 months
Center for Epidemiologic Studies Depression Scale (CES-D) Survey	Difference in CES-D survey results in each cohort at the follow up visits (3 and 6 months) compared to baseline visit. 20 questions, scale for each question between 0-3, higher score is associated with worse outcomes.	Baseline visit to 6 months
Visual Analog Scale (VAS) for pain	Difference in VAS Pain score in each cohort at the follow up visits (3 and 6 months) compared to baseline visit. Scale 0-100, higher score is associated with worse outcomes.	Baseline visit to 6 months
Antidepressant Side-Effect Checklist (ASEC)	Difference in ASEC score in each cohort at the follow up visits (3 and 6 months) compared to baseline visit. 21 questions, scale for each question between 0-3, higher score is associated with worse outcomes.	Baseline visit to 6 months

Collaborators and Investigators

• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
• Investigators: Principal Investigator: Richard Kim, MD, Western University, Canada

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Therapeutic drug monitoring; Pharmacogenetics; Personalized medicine
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Signs and Symptoms, Digestive; Cancer Pain; Vomiting; Adjustment Disorders
• Other Study ID Numbers: 11642 (DAIDS ES)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No