Occupational Exposure to Antineoplastic Drugs Among Physiotherapists in Healthcare Settings
NCT ID: NCT07328464
Last Updated: 2026-01-12
Study Results
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Basic Information
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NOT_YET_RECRUITING
20 participants
OBSERVATIONAL
2026-03-31
2027-03-31
Brief Summary
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To date, physiotherapists have been little studied in terms of occupational exposure, even though they frequently perform care practices (massage, lymphatic drainage, limb mobilisation, respiratory physiotherapy) involving direct, prolonged and sustained skin contact with patients treated with antineoplastic drugs; these compounds may be eliminated in the sweat of the treated patient for several days after administration.
In this context, the present study aims to assess the occupational exposure of physiotherapists to antineoplastic drugs in healthcare settings. The primary objective is to estimate the prevalence of internal contamination of physiotherapists by antineoplastic drugs after performing one of the care practices (massage, lymphatic drainage, limb mobilisation, respiratory physiotherapy) selected for the study, in patients receiving intravenous treatment with antineoplastic drugs.
The secondary objectives are to describe for each antineoplastic drug studied the prevalence, the frequency of internal contamination of physiotherapists, and urinary concentration levels, to characterise the circumstances of exposure and the personal protective equipment worn, to describe the prevalence and the frequency of external cutaneous contamination on the hands and forearms of physiotherapists after performing an exposing care practice, to quantify this external cutaneous contamination, to identify the factors associated with internal and external contamination, and to co-develop preventive measures in collaboration with physiotherapists and stakeholders and to assess their acceptability.
This study is a non-interventional (RIPH3), cross-sectional and multicenter study conducted at AP-HM (Public Assistance for Marseille hospitals) and Bordeaux University Hospital (CHU de Bordeaux). Twenty physiotherapists will be included in this study. Internal contamination will be assessed over 100 observation visits and external contamination over 70 observation visits (all participants combined). Observation visit include at least one " an exposing care practice" (massage, lymphatic drainage, limb mobilisation, respiratory physiotherapy) performed on a patient who received an intravenous antineoplastic drug from a predefined list, within a time window of 4 to 72 hours after the start of injection.
\- Internal contamination assessment (urine samples collection) For each observation visit, two urine samples of the physiotherapist participant will be collected: one sample within the 3 hours preceding the start of the work shift, and a second sample 6 to 10 hours after the end of the shift (or the next morning after waking up).
Data on exposure, activity and preventive practices (personal protective equipments worn) will be collected using an administered questionnaire (CRF). Information on the antineoplastic drugs administered to the patient receiving care by the physiotherapist will also be collected.
\- Cutaneous external contamination assessment (dermal wipe sampling) For each observation visit, the physiotherapist will apply a standardized hands and forearms washing protocol, observed by the clinical research technician. Then, cutaneous swab samples will be taken immediately after the washing.
The physiotherapist will then perform an exposing care practice, limiting contact with the environment (e.g., door handles/surfaces), and new samples will be taken immediately after the exposing care practice, without prior decontamination of hands and forearms. A total of eight cutaneous swab samples (four before and four after an exposing care practice) will be collected per observation visit, according to a protocol validated by the reference laboratory.
The assessment of cutaneous external contamination of physiotherapists will be evaluated during visits separate from those used to study internal contamination.
The expected outcomes of this study are: an individual assessment of exposure and potential internal contamination and/or external dermal contamination, for each physiotherapist; traceability of exposure in occupational health medical records, for each physiotherapist; improved knowledge on the proportion of contaminated physiotherapists (prevalence and frequency) and knowledge on urinary and cutaneous concentration levels of antineoplastic drugs in physiotherapists; increased awareness among physiotherapists regarding these exposures; implementation of co-developed preventive actions aiming to reduce exposures to the lowest possible level; and improved professional practices and working conditions.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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physiotherapists
physiotherapists exposed to antineoplastic drugs in healthcare settings
urine sample
Internal contamination of antineoplastic drugs
dermal wipe sampling
External contamination by antineoplastic drugs
questionnaires
Participants will have questionnaires
Interventions
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urine sample
Internal contamination of antineoplastic drugs
dermal wipe sampling
External contamination by antineoplastic drugs
questionnaires
Participants will have questionnaires
Eligibility Criteria
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Inclusion Criteria
Perform at least one physiotherapy treatment during this visit that must meet all of the following five criteria:
The physiotherapy treatment taken into account for this observation visit must be carried out in one of the healthcare departments selected for the study, This physiotherapy treatment being at least one of the following: massage and/or manual/lymphatic drainage and/or limb mobilisation and/or respiratory physiotherapy, This physiotherapy treatment being performed on a patient who has received intravenously at least one of the seven antineoplastic drugs studied, This physiotherapy treatment being performed within 4 to 72 hours of the start of intravenous administration of the antineoplastic drug(s) studied, This physiotherapy treatment is performed on a patient who is not in septic isolation and/or in a protected area.
Perform at least one physiotherapy treatment during this visit that must meet all of the following five criteria:
The physiotherapy treatment taken into account for this observation visit, must be carried out in one of the healthcare departments selected for the study, This physiotherapy treatment being at least one of the following: massage and/or manual/lymphatic drainage and/or limb mobilisation and/or respiratory physiotherapy, This physiotherapy treatment being performed on a patient who has received intravenously at least one of the twelve antineoplastic drugs studied, This physiotherapy treatment being performed within 4 to 72 hours of the start of intravenous administration of the antineoplastic drug(s) studied, This physiotherapy treatment is performed on a patient who is not in septic isolation and/or in a protected area.
Exclusion Criteria
Being assessed for the internal contamination on the same day as the external contamination assessment, Being treated with one of the seven antineoplastic drugs studied during the study or having been treated with one of them during the two months preceding the observation visit, Having a person and/or animal in their household who is being treated with one of the seven antineoplastic drugs during the study or in the two months prior to the observation visit.
Being assessed for the external contamination on the same day as the internal contamination assessment, Performing this physiotherapy treatment while wearing a long-sleeved gown and/or long-sleeved overgown, Performing this physiotherapy treatment while using a cream and/or gel and/or oil, Being treated oneself with one of the 12 antineoplastic drugs studied during the study or having been treated with one of them during the 2 months preceding the physiotherapy treatment, Having a person and/or animal in their household who is being treated with one of the 12 antineoplastic drugs during the study or in the 2 months prior to the physiotherapy treatment.
18 Years
ALL
Yes
Sponsors
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University Hospital, Bordeaux
OTHER
Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Francois Cremieux
Role: STUDY_DIRECTOR
AP-HM
Locations
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CHU de Bordeaux
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-A01689-40
Identifier Type: OTHER
Identifier Source: secondary_id
RCAPHM24_0277
Identifier Type: -
Identifier Source: org_study_id
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