Impact of Pharmacy Services on Gynaecology Chemotherapy Safety

February 10, 2025 updated by: Zhiqi Zhang, Peking University First Hospital

The Impact of Comprehensive Pharmaceutical Services on Medication Safety in Gynaecological Oncology Chemotherapy Patients

What was studied? We wanted to see whether having pharmacists closely involved in cancer care improves medication safety and reduces severe side effects for patients with gynecologic cancers (like ovarian or uterine cancer) during chemotherapy.

How was the study done?

Who participated? Patients receiving chemotherapy at Peking University First Hospital's Gynecologic Oncology Ward (September 2022-September 2024).

Two groups compared:

Standard care group: Pharmacists provided routine pharmaceutical services.

Full pharmacy care group: Pharmacists provided ongoing support, including:

Checking medications for safety.

Teaching patients how to manage side effects.

Answering questions about drugs.

Helping manage reactions like nausea or low white blood cells.

What was measured? Severe side effects (e.g., extreme nausea, appetite loss), how well doctors prescribed and monitored medications to boost white blood cells, and unplanned hospital stays.

Key findings:

Patients with full pharmacy care had:

Fewer severe side effects: Less extreme nausea, appetite loss, and dangerously low white blood cell counts.

Better management of blood cell-boosting medications: Doctors followed guidelines more closely, and patients received proper monitoring.

Fewer unplanned hospital visits: Likely due to better side effect prevention and early intervention.

Why does this matter?

For patients: Pharmacist support during chemotherapy may help you avoid severe side effects and reduce unexpected hospital stays.

For families: Knowing pharmacists are actively involved can provide reassurance about your loved one's medication safety.

For healthcare teams: Structured pharmacist collaboration improves adherence to treatment guidelines and patient outcomes.

Takeaway:

Full pharmacy care throughout chemotherapy helps protect patients' safety, reduces severe reactions, and supports smoother treatment journeys.

Study Overview

Study Type

Observational

Enrollment (Actual)

629

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

    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with gynaecological tumours receiving chemotherapy at our hospital

Description

Inclusion Criteria:

  • Patients diagnosed with gynaecologic malignancies such as ovarian cancer, cervical cancer, endometrial cancer, or gestational trophoblastic tumours.
  • Patients who received one of the following chemotherapy regimens: taxane monotherapy or combination therapy, anthracycline monotherapy or combination therapy, platinum-based monotherapy or combination therapy. These chemotherapy regimens could be combined with targeted therapy or immunotherapy.

Exclusion Criteria:

  • Patients treated with chemotherapy regimens outside those specified in the inclusion criteria.
  • Patients who received only targeted therapy, immunotherapy, endocrine therapy, bone-modifying therapy, or combinations of these treatments.

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
Intervention / Treatment
Control group
The control group received standard care: After the doctor issues the chemotherapy order, the oncology pharmacist only reviews the order to ensure that the chemotherapy regimen and pretreatment regimen during the study are consistent with those of the experimental group. No other interventions are performed.
Intervention group
The intervention group received comprehensive pharmaceutical care in addition to standard care. For first-cycle patients, oncology pharmacists conducted patient education, informing them about potential chemotherapy-induced adverse reactions and corresponding management strategies. Patients were instructed on the proper use of antiemetic medications, the recommended frequency of blood routine tests, and the appropriate timing, dosing, and administration of granulocyte colony-stimulating factor (G-CSF) and thrombopoietic agents. A QR code for oncology pharmacist consultation was provided to enable patients to seek advice on medication-related issues encountered outside the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of myelosuppression
Time Frame: From enrollment to the end of treatment at 3 weeks
From enrollment to the end of treatment at 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Degree of adverse gastrointestinal reactions
Time Frame: From enrollment to the end of treatment at 3 weeks
From enrollment to the end of treatment at 3 weeks
Readmission rate
Time Frame: From enrollment to the end of treatment at 3 weeks
From enrollment to the end of treatment at 3 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Chemotherapy-related adverse reactions
Time Frame: From enrollment to the end of treatment at 3 weeks
From enrollment to the end of treatment at 3 weeks

Collaborators and Investigators

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

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)

October 8, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

January 24, 2025

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024Y511-002
  • 2024SF58 (Other Grant/Funding Number: Peking University First Hospital, China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Hospital patient data needs to be kept confidential

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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