Clinical trial NCT06826950: Impact of Pharmacy Services on Gynaecology Chemotherapy Safety
Official title: The Impact of Comprehensive Pharmaceutical Services on Medication Safety in Gynaecological Oncology Chemotherapy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Gynaecological Oncology
Keywords: Pharmaceutical Services
Neoplasms
Chemotherapy
Gynaecological Oncology
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 629
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gynaecological tumours receiving chemotherapy at our hospital

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Degree of myelosuppression
timeFrame: From enrollment to the end of treatment at 3 weeks
Secondary outcomes:
measure: Degree of adverse gastrointestinal reactions
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Readmission rate
timeFrame: From enrollment to the end of treatment at 3 weeks
Other outcomes:
measure: Chemotherapy-related adverse reactions
timeFrame: From enrollment to the end of treatment at 3 weeks
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: