Pharmacotherapy Personalization of Cancer Patients

April 28, 2021 updated by: Agnieszka Bienert, Poznan University of Medical Sciences

Pharmacotherapy Personalization of Cancer Patients Based on Modern Analytical and Computational Techniques

Treatment personalization could ensure better outcome than standard procedures. It is particularly important in intensive care units where patients received many drugs and procedures. Their health status can change very fast. The oncologic patients treated in intensive care units are a special group of patients. Factors related to cancer influence extra their health status. The aim of this study is population pharmacokinetic-pharmacodynamic analysis drugs that are routinely used during an analgosedation in ICU oncologic patients. Analgosedation is monitored by drugs plasma concentration, the depth of sedation (bispectral index) and vital parameters like: systolic and diastolic blood pressure, mean arterial pressure, heart rate. Moreover, the TNM Staging System, biochemical parameters, The American Society of Anesthesiologists (ASA) physical status classification will be checked like potential factors influencing on pharmacokinetics and pharmacodynamics drugs used in the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The oncologic patients are qualified to head and neck tumor resection in general anesthesia. The anesthesia introduction is performed with single dose of midazolam, fentanyl, rocuronium and propofol/etomidate. Sevoflurane is used in anesthesia maintenance. Patients are transported to ICU after operation. Then they are kept for several hours in analgosedation. All used drugs are given by intravenous continuous infusion. Oxycodone is an analgesic component of analgosedation. Midazolam, dexmedetomidine and/or propofol are used as sedatives (2-3 drugs in every patient). Whole blood samples (2.0 ml) are collected during the study to measure drugs concentrations - 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation. Vital parameters and bispectral index are monitored during analgosedation and 6 hours after the infusion cessation and noted every 15-60 minutes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Greater Poland
      • Poznan, Greater Poland, Poland, 61-866
        • Greater Poland Cancer Centre
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-416
        • Medical University of Gdańsk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The adult patients with recognition of head and neck tumor who are qualified to tumor resection in general anesthesia and needing analgosedation in ICU after operation.

Description

Inclusion Criteria:

  • age over 18 years old,
  • qualifications to oncologic surgery,
  • needing of analgosedation in ICU after an operation

Exclusion Criteria:

  • proven allergies to used in anesthetics or/analgosedation medicaments,
  • lack of written confirmed consent of a patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Analgosedation in ICU patients after head and neck tumor resection in general anesthesia
Head and neck tumor resections were performed in general anesthesia. Midazolam and etomidate or propofol were used in introduction and then anesthesia was maintenance with sevoflurane. Patients received intravenous continuous infusion of oxycodone as an analgesic component and sedatives (propofol/dexmedetomidine/midazolam) during analgosedation in ICU.
Drug: Infusion Intravenous
Other Names:
  • Analgesics and sedatives intravenous continuous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement of the depth of sedation using bispectral index
Time Frame: from the beginning of analgosedation to 6 hours after analgosedation
Continuous measurement of the depth of sedation using bispectral index during analgosedation in intensive care unit.
from the beginning of analgosedation to 6 hours after analgosedation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oxycodone plasma concentrations [ng/ml]
Time Frame: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Measurements of oxycodone and noroxycodone plasma concentrations [ng/ml] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.
3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Dexmedetomidine plasma concentrations [ng/ml]
Time Frame: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Measurements of dexmedetomidine plasma concentrations [ng/ml] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.
3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Midazolam plasma concentrations [ng/ml]
Time Frame: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Measurements of midazolam and alfa-hydroxymidazolam plasma concentrations [ng/ml] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.
3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Propofol plasma concentrations [ng/ml]
Time Frame: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Measurements of propofol plasma concentrations [ng/ml] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.
3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Systolic blood pressure
Time Frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Measurements of systolic blood pressure during analgosedation in intensive care unit.
before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Diastolic blood pressure
Time Frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Measurements of diastolic blood pressure during analgosedation in intensive care unit.
before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Heart rate
Time Frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Measurements of heart rate during analgosedation in intensive care unit.
before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Mean arterial pressure
Time Frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Measurements of mean arterial pressure during analgosedation in intensive care unit.
before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of Gdansk
The Greater Poland Cancer Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Agnieszka Bienert, MSC, PhD, Poznan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 763/2016
  • 2015/17/B/NZ7/03032 (Other Grant/Funding Number: Polish National Science Centre)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

pharmacokinetic and pharmacodynamic data (concentration/effect/time profiles) of individuals will be available

IPD Sharing Time Frame

The data will be available in 6-12 months and available for 5 years

IPD Sharing Access Criteria

Scientists

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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