Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer

Trial Title: Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer

NCT ID: NCT05830279

Condition: Nausea With Vomiting Chemotherapy-Induced
Depression, Reactive
Cancer Pain

Conditions: Official terms:
Vomiting
Cancer Pain
Adjustment Disorders

Conditions: Keywords:
Personalized medicine
Pharmacogenetics
Therapeutic drug monitoring

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Genetic
Intervention name: Pharmacogenetic testing
Description: Genotyping for CYP2D6 and CYP2C19
Arm group label: Anti-depressants
Arm group label: Anti-metics
Arm group label: Opioid pain medications

Intervention type: Other
Intervention name: Drug-Drug interaction analysis
Description: Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.
Arm group label: Anti-depressants
Arm group label: Anti-metics
Arm group label: Opioid pain medications

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.

Detailed description: 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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Lawson Health Research Institute

Address:
City: London
Zip: N6C 2R5
Country: Canada

Status: Recruiting

Start date: May 1, 2023

Completion date: April 30, 2025

Lead sponsor:
Agency: Lawson Health Research Institute
Agency class: Other

Source: Lawson Health Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05830279