Recruiting

Personalized Medicine

Sponsor:

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

Code:

NCT05830279

Conditions

Nausea With Vomiting Chemotherapy-Induced

Depression, Reactive

Cancer Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pharmacogenetic testing

Drug-Drug interaction analysis

Study Details

Brief summary:

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.

Conditions

Nausea With Vomiting Chemotherapy-Induced

Depression, Reactive

Cancer Pain

Study ID

NCT05830279

Start date

May 1, 2023

Status verified date

Jul, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Opioid pain medications

Patients who have been prescribed opioid pain medications including codeine, oxycodone, hydrocodone, or tramadol.

Anti-metics

Patients who have been prescribed the antiemetic agent ondansetron

Interventions

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.

Primary outcome measure

  • Drug level measurements [ Time Frame: Baseline visit to 6 months ]

Central Contacts and Locations

Central contacts

Richard Kim, MD

519-685-8500richard.kim@lhsc.on.ca

Samantha Medwid, PhD

519-685-8500samantha.medwid@lhsc.on.ca

Locations

Lawson Health Research Institute

Recruiting

London, Ontario, Canada, N6C 2R5

More Information

Sponsor

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

Last update posted

Jul 9, 2025

Last verified

Jul, 2025

Keywords

  • Personalized medicine
  • Pharmacogenetics
  • Therapeutic drug monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-07-09.