NeoplasmsNCT06826950
Impact of Pharmacy Services on Gynaecology Chemotherapy Safety
An observational study of Neoplasms and Gynaecological Oncology, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplasms, Gynaecological Oncology
- What is being tested?
- comprehensive pharmaceutical care and Routine pharmaceutical services
- How many people
- 629 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2024to 24 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gynaecological tumours receiving chemotherapy at our hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: 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?
Read more
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.
- Conditions
- Neoplasms, Gynaecological Oncology
- Being tested
- comprehensive pharmaceutical care, Routine pharmaceutical services
- Keywords
- Pharmaceutical Services, Neoplasms, Chemotherapy, Gynaecological Oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive pharmaceutical careOther
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.
Routine pharmaceutical servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described Receives: Other: Routine pharmaceutical services | |
| Intervention group | Not described Receives: Other: comprehensive pharmaceutical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of myelosuppression
Measured: From enrollment to the end of treatment at 3 weeks
Secondary outcomes (2)
Degree of adverse gastrointestinal reactions
Measured: From enrollment to the end of treatment at 3 weeks
Readmission rate
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start8 Oct 2024
- Primary completion31 Dec 2024
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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-control
- Time perspective
- Retrospective
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiqi Zhang, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826950
- Sponsor's protocol ID
- 2024Y511-002
- Other IDs
- 2024SF58
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital patient data needs to be kept confidential
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Comprehensive Pharmaceutical Services on Medication Safety in Gynaecological Oncology Chemotherapy Patients
- ClinicalTrials.gov ID
- NCT06826950
- Acronym / sponsor ID
- 2024Y511-002
- Conditions
- Neoplasms, Gynaecological Oncology
- Keywords
- Pharmaceutical Services, Neoplasms, Chemotherapy, Gynaecological Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Routine pharmaceutical services |
| Intervention group | – | Other: comprehensive pharmaceutical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gynaecological tumours receiving chemotherapy at our hospital
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive pharmaceutical careThe 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. | Other | Intervention group |
| Routine pharmaceutical servicesThe 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. | Other | Control group |
Primary outcome
Degree of myelosuppression
Time frame: From enrollment to the end of treatment at 3 weeks
2 secondary outcomes
Degree of adverse gastrointestinal reactions
Time frame: From enrollment to the end of treatment at 3 weeks
Readmission rate
Time frame: From enrollment to the end of treatment at 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No. Hospital patient data needs to be kept confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Gynaecological Oncology, run by Peking University First Hospital at 1 site in China.
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: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of myelosuppression (time frame: From enrollment to the end of treatment at 3 weeks). 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 14 Feb 2025.