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NCT Number: NCT05830279

Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lawson Health Research Institute

London, Ontario, N6C 2R5, Canada

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pharmacogenetic testing

Genetic

Genotyping for CYP2D6 and CYP2C19

Drug-Drug interaction analysis

Other

Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.

Primary outcomes

  1. Drug level measurements

    Time frame: Baseline visit to 6 months

    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

Secondary outcomes

  1. Edmonton Symptom Assessment Scale (ESAS) Survey

    Time frame: Baseline visit to 6 months

    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.

  2. Center for Epidemiologic Studies Depression Scale (CES-D) Survey

    Time frame: Baseline visit to 6 months

    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.

  3. Visual Analog Scale (VAS) for pain

    Time frame: Baseline visit to 6 months

    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.

  4. MASCC Antiemesis Tool (MAT) survey

    Time frame: Baseline visit to 6 months

    Difference in MAT survey results in each cohort at the follow up visits (3 and 6 months) compared to baseline visit

  5. Antidepressant Side-Effect Checklist (ASEC)

    Time frame: Baseline visit to 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Richard Kim, MD

CONTACT

[email protected]

519-685-8500 ext. 33553

Samantha Medwid, PhD

CONTACT

[email protected]

519-685-8500 ext. 32099

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2023
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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