Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer

NCT05830279 | Recruiting

• 1 other identifier: 11642
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Keywords

Personalized medicine; Pharmacogenetics; Therapeutic drug monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Edmonton Symptom Assessment Scale (ESAS) Survey

  Baseline visit to 6 months

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

  Baseline visit to 6 months

• Visual Analog Scale (VAS) for pain

  Baseline visit to 6 months

• MASCC Antiemesis Tool (MAT) survey

  Baseline visit to 6 months

• Antidepressant Side-Effect Checklist (ASEC)

  Baseline visit to 6 months

Study Arms (3)

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; Other: Drug-Drug interaction analysis

Opioid pain medications

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

Genetic: Pharmacogenetic testing; Other: Drug-Drug interaction analysis

Anti-metics

Patients who have been prescribed the antiemetic agent ondansetron

Genetic: Pharmacogenetic testing; Other: Drug-Drug interaction analysis

Interventions

Pharmacogenetic testing GENETIC

Genotyping for CYP2D6 and CYP2C19

Anti-depressants; Anti-metics; Opioid pain medications

Drug-Drug interaction analysis OTHER

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

Anti-depressants; Anti-metics; Opioid pain medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Lawson Health Research Institute

London, Ontario, N6C 2R5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected at each in-person appointment for extraction of DNA (genotype) and plasma (drug level analysis).

MeSH Terms

Conditions

Adjustment Disorders; Cancer Pain

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Richard Kim, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Kim, MD

CONTACT

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

Samantha Medwid, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 26, 2023
• Study Start: May 1, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)