Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer

Cancer Pain Clinical Trial

Official title:

Evaluating the Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer Patients: A Prospective Longitudinal Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830279
• Other study ID #: 11642
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: Richard Kim, MD
• Phone: 519-685-8500
• Email: richard.kim[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adjustment Disorders
• Cancer Pain
• Depression, Reactive
• Nausea With Vomiting Chemotherapy-Induced
• Vomiting

Intervention

Genetic:
• Pharmacogenetic testing
Genotyping for CYP2D6 and CYP2C19

Other:
• Drug-Drug interaction analysis
Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Edmonton Symptom Assessment Scale (ESAS) Survey	Difference in ESAS survey results in each cohort at the follow up visits (3 and 6 months) compared to baseline visit	Baseline visit to 6 months
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D) Survey	Difference in CES-D survey results in each cohort at the follow up visits (3 and 6 months) compared to baseline visit	Baseline visit to 6 months
Secondary	Visual Analog Scale (VAS) for pain	Difference in VAS Pain score in each cohort at the follow up visits (3 and 6 months) compared to baseline visit	Baseline visit to 6 months
Secondary	MASCC Antiemesis Tool (MAT) survey	Difference in MAT survey results in each cohort at the follow up visits (3 and 6 months) compared to baseline visit	Baseline visit to 6 months
Secondary	Antidepressant Side-Effect Checklist (ASEC)	Difference in ASEC score in each cohort at the follow up visits (3 and 6 months) compared to baseline visit	Baseline visit to 6 months