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Completed

NCT Number: NCT04142567

Role of the Pharmacist in Detection of Drug Interactions Before Antitumor Treatment Initiation

The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.

The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases. The primary endpoint is the prevalence of pharmacist interventions among patients who are going to receive an oral targeted therapy or cancer chemotherapy or immunotherapy

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

APHP -Cochin Hospital and Georges Pompidou European Hospital

Paris, 75014, France

About this study

The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.

The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases.

The primary endpoint is the prevalence of pharmacist interventions among cancer patients who are going to receive an oral targeted therapy (140 patients) or cancer chemotherapy or immunotherapy (300 patients).

Pharmacist interventions will be classified according to the SFPC (société française de pharmacie Clinique) classification.

The secondary endpoints are

  • The detection of drug drug interactions with theriaque software, Micromedex software and DDI predictor tool.
  • The clinical gradation by an independent expert comity of the clinical impact of avoided drug drug interaction. The expert comity will grade avoided clinical consequences in 3 levels (minor, moderate or major),
  • The Economic evaluation of pharmacist intervention: Cost of the project to evaluate drug drug interaction and benefits after evaluation of avoided clinical consequences
  • The Adherence evaluation of patients treated with oral cancer targeted therapy (Therefore, only patients under oral targeted therapy will be evaluated at Day0, Day15 ,Day 30 and Month 6 to determine adherence.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • legal age patients
  • Affiliated to social security or with another insurance system
  • with a solid tumor
  • who are going to receive an antitumor treatment (chemotherapy, immunotherapy or oral targeted therapy)

Exclusion criteria

  • pregnant women
  • minor patient

Treatment and study plan

Primary outcomes

  1. Prevalence of Pharmacist intervention

    Time frame: up to 1 week from date of inclusion

    Percentage of patients whom antitumora treatment or usual treatment has been changed by the pharmacist intervention

Secondary outcomes

  1. Detection of Drug -drug interactions

    Time frame: up to 1 week from date of inclusion

    Number of drug drug interactions detected

  2. Clinical gradation of drug drug interactions

    Time frame: One year

    Gradation by an independent experts comity of the clinical impact of prevented drug drug interaction

  3. Cost of the pharmacist intervention by avoided clinical consequence

    Time frame: One year

    Cost evaluation of pharmacist for analysis and medication review with patient by avoided interaction

  4. Potential cost of the avoided clinical consequences

    Time frame: One year

    Treatment cost of avoided clinical consequences , balanced with the probability of occurrence

  5. Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring

    Time frame: day 15, 30 and 6 months after oral therapy initiation

    Patients with plasma drug concentration below the 10th percentile will be classified as nonadherent patients

  6. Adherence evaluation with oral cancer targeted therapy by the 6 item-Girerd Scale

    Time frame: day 15, 30 and 6 months after oral therapy initiation

    Patients with a Girerd score greater than or equal to 3 will be classified as nonadherent patients

  7. Adherence evaluation with oral cancer targeted therapy by pill count

    Time frame: 6 months after oral therapy initiation

    Pill counts will be used to calculate the percent of total prescribed dose taken to prescribed during the 90-day period

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Role of the Clinical Pharmacist in an Oncology Ambulatory Center to Prevent Drug Related Problems Before Antitumor Treatment Initiation

Acronym: CHOPIN

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2019
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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