- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06826950
Impact of Pharmacy Services on Gynaecology Chemotherapy Safety
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100034
- Peking University First Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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