Nurses Internal Contamination by Antineoplastic Drugs. (CACIES)

Assessment of Nurses Internal Contamination by Antineoplastic Drugs in Hospital Centers.

CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs.

Study Overview

• Status: Completed
• Conditions: Antineoplastic Drugs Contamination Prevalence
• Intervention / Treatment: Other: Nurses urine samples

Detailed Description

The increase of cancer incidence contributes to a growing number of administered chemotherapies in care services. These antineoplastic drugs are not selective in their mechanisms of action, affecting noncancerous as well as cancerous cells, leading to several known side effects in treated patients. Health care professionals are increasingly exposed to antineoplastic drugs and can be potentially contaminated by these molecules. This is a key concern as part of assessment and occupational risk management in healthcare settings.

Occupational Health and Safety Department, in collaboration with Clinical and Toxicology Laboratory of university Hospital Bordeaux, developed analytical tools to assess this contamination in health care professional's urines, and the new acquisition of a high-sensitivity measurement equipment (LC-MS/MS) improved assays methods in terms of sensitivity and detection limits.

The main objective of the study is to assess internal contamination prevalence by the studied antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate) in nursing staff who administers these chemotherapies or is in charge of patients treated by these chemotherapies, in two French hospital centers: University Hospital Bordeaux and IUCT-Oncopole of Toulouse (Institut Universitaire du Cancer de Toulouse), including about fifteen services selected on their use of these specific chemotherapies.

The secondary objectives of the study are on the one hand, to describe for each of the five studied antineoplastic drugs the internal contamination prevalence in nursing staff, and concentration level associated to this contamination in contaminated nursing staff, and on the other hand, to identify contamination-associated factors in exposure characteristics and personal protective equipment use.

This is a descriptive, multicentre, transverse and prospective study.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Hopital Pellegrin
  • Toulouse, France, 31000
    • CHU de Toulouse
  • Toulouse, France, 31000
    • IUCT-Oncopole

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Nurses working in anticancer unit.

Description

Inclusion Criteria:

• To be a nurse with Registered Nurse Licensure (IDE: Infirmier Diplômé d'Etat), practising in one of the selected services in Bordeaux teaching hospital or in IUCT-Oncopole,
• To have used at least one of the five antineoplastic drugs and/or to have cared one patient treated by one of the five antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate) in the workday of participation to the study (day with urine samples),
• To have accepted to participate to the study and signed the participation consent form.

Exclusion Criteria:

• To be a nursing student,
• To be treated or to have been treated in the year before the workday of study participation by one of the five antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate)
• To have at home, someone treated by one of the five antineoplastic drugs in the month before the workday of study participation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nurses in contact with chemotherapies; It is a nurses cohort, who administer chemotherapies or are in charge of patients treated by chemotherapie. Three urine samples are collected: first : between 0 to 3h before the beginning of the workday second : between 0 to 2h after the end of the workday third : between 7 to 10h after the end of the workday	Other: Nurses urine samples; Collected urine samples from nurses in contact with antineoplastic drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internal contamination by at least one antineoplastic drug.	Presence or absence of internal contamination by at least one antineoplastic drug of the five studied antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate) in at least one of the three urine samples collected by subject.	inclusion day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nurses contamination prevalence.	5 studied antineoplastic drugs concentration in urine samples.	inclusion day
Socio-demographic factors.	Assessed by age, sexe, pregnancy, cigarette addiction questionnaire	inclusion day
Practical work conditions.	Assessed by practical work conditions questionnaires.	inclusion day
Patients management treated by 5 studied antineoplastic drugs.	Assessed by practical work conditions questionnaires.	inclusion day
Safety equipment use.	Assessed by safety equipment questionnaire	inclusion day

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Bordeaux PharmacoEpi
• Investigators: Study Chair: PARIENTE Antoine, Pr, Bordeaux PharmacoEpi (BPE)

Publications and helpful links

General Publications

• Villa A, Molimard M, Bignon E, Martinez B, Rouyer M, Mathoulin-Pelissier S, Baldi I, Verdun-Esquer C, Canal-Raffin M. Study protocol for the assessment of nurses internal contamination by antineoplastic drugs in hospital centres: a cross-sectional multicentre descriptive study. BMJ Open. 2019 Nov 10;9(11):e033040. doi: 10.1136/bmjopen-2019-033040.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: biomonitoring; occupational exposure; antineoplastic drugs
• Other Study ID Numbers: CHUBX 2013/30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No