Nurses Internal Contamination by Antineoplastic Drugs.

Antineoplastic Drugs Contamination Prevalence Clinical Trial

— CACIES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137641
• Other study ID #: CHUBX 2013/30
• Status: Completed
• Start date: October 16, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: May 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Antineoplastic Drugs Contamination Prevalence

Intervention

Other:
• Nurses urine samples
Collected urine samples from nurses in contact with antineoplastic drugs.

Locations

Country	Name	City	State
France	Hôpital Pellegrin	Bordeaux
France	CHU de Toulouse	Toulouse
France	IUCT-Oncopole	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Bordeaux PharmacoEpi

Country where clinical trial is conducted

France, 

Outcome

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