NCT05830279 Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer
| NCT ID | NCT05830279 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Nausea With Vomiting Chemotherapy-Induced |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2023-05-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Richard Kim, MD
PRINCIPAL INVESTIGATOR
Western University, Canada
Frequently Asked Questions
Who can join the NCT05830279 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nausea With Vomiting Chemotherapy-Induced. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05830279 currently recruiting?
Yes, NCT05830279 is actively recruiting participants. Contact the research team at richard.kim@lhsc.on.ca for enrollment information.
Where is the NCT05830279 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT05830279 clinical trial?
NCT05830279 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Richard Kim, MD at Western University, Canada. The trial plans to enroll 600 participants.