RecruitingNCT05830279

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


Sponsor

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

Enrollment

600 participants

Start Date

May 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using genetic testing to see how each cancer patient's genes affect how their body processes certain medications — particularly antidepressants and pain medications — and whether adjusting drug choices based on this information leads to better outcomes and fewer side effects. **You may be eligible if...** - You are 18 years or older with a cancer diagnosis - You are currently receiving chemotherapy - You are currently taking at least one of the following medications: citalopram, escitalopram, venlafaxine, desvenlafaxine, codeine, oxycodone, hydrocodone, tramadol, or ondansetron **You may NOT be eligible if...** - You are unable to complete study surveys (with or without assistance) - You do not speak English - You are receiving palliative (end-of-life) care only - You are taking an antidepressant for a reason other than depression or anxiety (e.g., for hot flashes) — only applies to the antidepressant group - You had a major depressive disorder before your cancer diagnosis — only applies to the antidepressant group Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICPharmacogenetic testing

Genotyping for CYP2D6 and CYP2C19

OTHERDrug-Drug interaction analysis

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


Locations(1)

Lawson Health Research Institute

London, Ontario, Canada

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NCT05830279


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