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Cytotoxic DrugKAP CDsNCT06857656

Knowledge, Attitudes and Practices of Safe Handling of CDs

An observational study of Cytotoxic Drug, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Cancer is a leading contributor to global disease burden, with nearly 20 million new cases diagnosed every year . Cancer patients usually receive a combination of treatments involving surgery, radiation, and/or systemic drug therapy. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Cytotoxic Drug
How many people
50 participants
Where
No sites listed yet
Study dates
1 Apr 2025to 1 May 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Healthcare workers (nurses and clinical pharmacists) employed in the tertiary care unit. At least one year of work experience in the hospital. Exposure to chemotherapy drugs

Who may be able to join

  • Healthcare workers (nurses and clinical pharmacists) employed in the tertiary care unit.
  • At least one year of work experience in the hospital. Exposure to chemotherapy drugs

Who cannot join

  • Healthcare workers not involved in direct patient care or medication administration.
  • Workers with pre-existing conditions that may be influenced by factors unrelated to drug exposure (e.g., other environmental toxins).

About this study

Official title: Knowledge, Attitudes and Practices of Safe Handling of Cytotoxic Drugs Among Oncology Nurses and Clinical Pharmacists in Tertiary Care Unit

Cancer is a leading contributor to global disease burden, with nearly 20 million new cases diagnosed every year . Cancer patients usually receive a combination of treatments involving surgery, radiation, and/or systemic drug therapy.

Antineoplastic drugs (ADs), also known as chemotherapy or cytotoxic drugs, include compounds with various mechanisms of action that are used to fight the global burden of cancer, preventing or disrupting cell division of neoplastic cells. Also, Antineoplastic drugs are being used increasingly to treat arthritis, multiple sclerosis, and other non-cancer medical conditions.

Read more

However, their action on malignant cells is only partially selective and normal cells may also be affected, leading to significant toxic side effects.

Healthcare workers, particularly those working in oncology units, face the possibility of exposure to hazardous antineoplastic drugs, which are known to cause long-term health effects such as cancer, reproductive toxicity, and other chronic health issues. However, there is a gap in research specifically focused on exposure levels and health risks for nurses and pharmacists in tertiary care hospitals. Understanding the impact of this exposure and implementing proper preventive measures is crucial for ensuring the safety of healthcare workers.

The aim of the study:

General objectives: Evaluate the extent of exposure to a The widespread use of CDs has raised concern about the risks health care workers who use them.

Anyone working with patients (or animals) receiving cytotoxic drugs is at risk of exposure. This includes pharmacists, pharmacy technicians, medical and nursing staff, laboratory staff and Veterinary practitioners in which they are all at risk when using cytotoxics. Appropriate control measures must be in place to protect them all Occupational exposure to cytotoxic drugs (CDs) and related wastes may occur during preparing, administering, transporting, storing drugs and when handling cytotoxic waste, transporting and disposing of waste, and cleaning up spills. Exposure to those drugs may occur through skin absorption, inhalation of aerosols and drug droplets, eye contact through a splash of liquids, ingestion, and through needle stick injuries.

In Egypt, the burden of cancer is high; there is low number of nurses especially oncology certified nurses in compared to the patient's number. This makes nurses overwhelmed and frustrated, so, more exposed to CDs hazards.

Acute health effects related to this occupational exposure include hair loss, skin rash, eczema, skin flush, light headedness, nausea, dizziness, vomiting and gastrointestinal symptoms. While the long-term exposure may cause adverse reproductive outcomes including menstrual irregularities, infertility, spontaneous abortion and congenital malformation.

We need to mention results of previous studies Health care workers who handle CDs must be aware of the existing hazards and safe handling practices of cytotoxic drugs because this has been associated with improvement of safety of both patients and health care workers. Previous Egyptian studies show weak compliance of nurses' practice with safe-handling guidelines.

Safe handling of antineoplastic agents is a primary concern among health care workers (HCWs) due to the harmful effects of CDs. Various organizations like National Institute for Occupational Safety and Health (NIOSH), Occupational Safety and Health Administration (OSHA), American Society of Hospital Pharmacist (ASHP), the Oncology Nursing Society and American Society of Clinical Oncology (ASCO) have recommended safe handling practice guidelines for anti-cancer drugs. These guidelines suggest the application of hierarchy of various strategies of mitigating and controlling workplace hazards. All HCWs must follow these safety guidelines.

Some of the guidelines include modifying the physical structure of the workplace in terms of isolating the drug preparation space, minimizing nurses' contact with the drug, applying standard work methods and utilizing personal protective equipment to achieve the minimum contact of the antineoplastic drugs with the skin or respiratory system of HCWs.

A study was done in Ain Shams University Hospitals in 2019 by El Hosseini DM; Ghanem EA; Gamal DA and demonstrate that almost more than half of the study nurses frequently complained from recurrent headache (64.4%), skin irritation (63%), eye irritation (61.6%), and hair loss (52.1%). Reproductive effects were also found: menstrual irregularities (32.9%), low birth weight babies (23.3%), premature labor (19.2%), and malignancy (15.1%). During handling CDs, the majority of nurses (89%) utilized gloves, (61.6%) utilized gowns, and none of them utilized goggles. About (72. %) had fair total knowledge score regarding CDs, and only few of them (11.0 %) had good total In the last four decades, several studies have reported detectable and/or quantifiable concentrations of such hazardous drugs both in wor

Read the detailed description

Cancer is a leading contributor to global disease burden, with nearly 20 million new cases diagnosed every year . Cancer patients usually receive a combination of treatments involving surgery, radiation, and/or systemic drug therapy.

Antineoplastic drugs (ADs), also known as chemotherapy or cytotoxic drugs, include compounds with various mechanisms of action that are used to fight the global burden of cancer, preventing or disrupting cell division of neoplastic cells. Also, Antineoplastic drugs are being used increasingly to treat arthritis, multiple sclerosis, and other non-cancer medical conditions.

However, their action on malignant cells is only partially selective and normal cells may also be affected, leading to significant toxic side effects.

Healthcare workers, particularly those working in oncology units, face the possibility of exposure to hazardous antineoplastic drugs, which are known to cause long-term health effects such as cancer, reproductive toxicity, and other chronic health issues. However, there is a gap in research specifically focused on exposure levels and health risks for nurses and pharmacists in tertiary care hospitals. Understanding the impact of this exposure and implementing proper preventive measures is crucial for ensuring the safety of healthcare workers.

The aim of the study:

General objectives: Evaluate the extent of exposure to a The widespread use of CDs has raised concern about the risks health care workers who use them.

Anyone working with patients (or animals) receiving cytotoxic drugs is at risk of exposure. This includes pharmacists, pharmacy technicians, medical and nursing staff, laboratory staff and Veterinary practitioners in which they are all at risk when using cytotoxics. Appropriate control measures must be in place to protect them all Occupational exposure to cytotoxic drugs (CDs) and related wastes may occur during preparing, administering, transporting, storing drugs and when handling cytotoxic waste, transporting and disposing of waste, and cleaning up spills. Exposure to those drugs may occur through skin absorption, inhalation of aerosols and drug droplets, eye contact through a splash of liquids, ingestion, and through needle stick injuries.

In Egypt, the burden of cancer is high; there is low number of nurses especially oncology certified nurses in compared to the patient's number. This makes nurses overwhelmed and frustrated, so, more exposed to CDs hazards.

Acute health effects related to this occupational exposure include hair loss, skin rash, eczema, skin flush, light headedness, nausea, dizziness, vomiting and gastrointestinal symptoms. While the long-term exposure may cause adverse reproductive outcomes including menstrual irregularities, infertility, spontaneous abortion and congenital malformation.

We need to mention results of previous studies Health care workers who handle CDs must be aware of the existing hazards and safe handling practices of cytotoxic drugs because this has been associated with improvement of safety of both patients and health care workers. Previous Egyptian studies show weak compliance of nurses' practice with safe-handling guidelines.

Safe handling of antineoplastic agents is a primary concern among health care workers (HCWs) due to the harmful effects of CDs. Various organizations like National Institute for Occupational Safety and Health (NIOSH), Occupational Safety and Health Administration (OSHA), American Society of Hospital Pharmacist (ASHP), the Oncology Nursing Society and American Society of Clinical Oncology (ASCO) have recommended safe handling practice guidelines for anti-cancer drugs. These guidelines suggest the application of hierarchy of various strategies of mitigating and controlling workplace hazards. All HCWs must follow these safety guidelines.

Some of the guidelines include modifying the physical structure of the workplace in terms of isolating the drug preparation space, minimizing nurses' contact with the drug, applying standard work methods and utilizing personal protective equipment to achieve the minimum contact of the antineoplastic drugs with the skin or respiratory system of HCWs.

A study was done in Ain Shams University Hospitals in 2019 by El Hosseini DM; Ghanem EA; Gamal DA and demonstrate that almost more than half of the study nurses frequently complained from recurrent headache (64.4%), skin irritation (63%), eye irritation (61.6%), and hair loss (52.1%). Reproductive effects were also found: menstrual irregularities (32.9%), low birth weight babies (23.3%), premature labor (19.2%), and malignancy (15.1%). During handling CDs, the majority of nurses (89%) utilized gloves, (61.6%) utilized gowns, and none of them utilized goggles. About (72. %) had fair total knowledge score regarding CDs, and only few of them (11.0 %) had good total In the last four decades, several studies have reported detectable and/or quantifiable concentrations of such hazardous drugs both in work

Rational of the study:

Healthcare workers, particularly those working in oncology units, face the possibility of exposure to hazardous antineoplastic drugs, which are known to cause long-term health effects such as cancer, reproductive toxicity, and other chronic health issues. However, there is a gap in research specifically focused on exposure levels and health risks for nurses and pharmacists in tertiary care hospitals. Understanding the impact of this exposure and implementing proper preventive measures is crucial for ensuring the safety of healthcare workers.

The aim of the study:

General objectives: Evaluate the extent of exposure to antineoplastic drugs among nurses and clinical pharmacists in a tertiary care unit and to examine the potential health effects associated with such exposure.

Specific objectives:

  1. Determine the levels of exposure to antineoplastic drugs in the workplace among healthcare workers.
  2. Compare the health status of those exposed to antineoplastic drugs with those who are not exposed.
  3. Identify any protective measures that are currently in place and their effectiveness in reducing exposure.
Conditions
Cytotoxic Drug
Keywords
occpational hazards

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06857656
Study groupRoleWhat they receive
cytotoic handular workersNurses and Clinical Pharmacists work in South Egypt Cancer Institute and Department of Clinical Oncology and Nuclear Medicine in Assiut university Hospital. At least one year of work experience in the hospital. Exposure to chemotherapy drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total KAP score

    The knowledge score ranged from 0 to 26. Nurses who achieved ≥ 75% of the score (i.e. ≥ 20) were classified as having satisfactory knowledge, those who scored <75%were considered to have unsatisfactory knowledge. Regarding the attitude, the score ranged from 0 to 16. Nurses who achieved ≥ 75% of the attitude score (i.e. ≥ 12) were considered to have a positive attitude, while score less than 75% was considered as a negative one. For practice, the score ranged from 0 to 12. Nurses who obtained ≥ 75% of the score (i.e. ≥ 9) were classified as having adequate practice while those who achieved less than < 75% were classified as having inadequate practice. Total KAP ranged from 0-54, nurses who achieved ≥ 75% of the total score (≥ 41) were classified as having a satisfactory KAP, while obtaining less than 75% was considered as an unsatisfactory KAP.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06857656
Sponsor's protocol ID
KAP of handeling CDs
Acronym
KAP CDs
Status last verified
Feb 2025
First submitted
27 Feb 2025
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cytotoxic Drug, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total KAP score (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.

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