Breast CancerNCT07533526
Effects of Instrument-Assisted Constant-Speed Injection Versus Manual Injection on Pain From Large-Volume Subcutaneous Injection of Pertuzumab and Trastuzumab in Breast Cancer: A Randomized, Self-Controlled Study
A study testing Instrument-driven constant-rate injection in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Research Background:Subcutaneous injection is an important route of administration in targeted therapy for breast cancer, but injection pain affects patients' treatment experience. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Instrument-driven constant-rate injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 30 Oct 2026
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female breast cancer patients histologically confirmed as HER2-positive.
- Have completed at least one subcutaneous injection of Phesgo, with at least three planned injections remaining.
- No history of acute allergic reactions (e.g., Grade 1-2 allergic reactions) during previous Phesgo injections.
- Aged between 18 and 70 years (inclusive).
- No use of pain medications, pain patches, or pain pumps for pain management within 3 days prior to injection.
- Normal activity level (ECOG score 0-2), no limb paralysis, and able to clearly express personal feelings.
- Signed informed consent form and voluntarily agreed to participate in this study.
Who cannot join
- Presence of any skin diseases or conditions affecting subcutaneous injection (e.g., severe infection or dermatitis at the injection site).
- Simultaneous participation in other clinical trials that may interfere with the results of this study.
- Cognitive impairment or mental illness preventing completion of study questionnaires and assessments.
- Regular use of analgesics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Li Yan, Bachelor's Degree, +86-81332587, sysmhmec@mail.sysu.edu.cn
Yanting Peng, Bachelor's Degree
About this study
Research Background:Subcutaneous injection is an important route of administration in targeted therapy for breast cancer, but injection pain affects patients' treatment experience. Fluctuations in injection speed during traditional manual push may be one of the factors exacerbating pain, whereas machine-driven injection can provide a constant flow rate, theoretically reducing pain; however, high-quality evidence is lacking.
Research Objective:To compare the difference in pain intensity between instrument constant-speed injection and manual injection in breast cancer patients receiving subcutaneous injection of pertuzumab and trastuzumab.
Read more
Research Methods:A randomized self-controlled design is used, with data analysis performed using paired t-tests. The study plans to enroll 40 female breast cancer patients. Each patient receives two injection methods across two treatment cycles: instrument constant-speed injection (medical infusion pump, 2 mL/min) and manual injection (a nurse uses a stopwatch to time and simulates the injection pump speed of 2 mL/min). The order of injection methods is randomly assigned by drawing lots (the injection method for the first cycle is randomly drawn, and the method for the second cycle is naturally the alternative method). The primary outcome is the patient's most severe pain during injection, measured immediately after injection using the Numerical Rating Scale (NRS, 0-10). Secondary outcomes include injection site reactions, patient satisfaction, nurse fatigue (Borg CR10 scale), patient preference, and safety indicators.
Research Significance:The results of this study will provide high-level evidence for selecting comfortable and efficient subcutaneous injection techniques in clinical practice, thereby improving patients' treatment experience.
- Conditions
- Breast Cancer
- Being tested
- Instrument-driven constant-rate injection
- Keywords
- Breast cancer, Pertuzumab and Trastuzumab, Large volume subcutaneous injection, Instrument-driven constant-rate injection / manual injection, Pain
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument-driven constant-rate injectionOther
Drug preparation followed the standard procedure. A fixed team of two nurses, trained according to the study protocol, performed manual injection. The nurses, after training, simulated the speed of the machine injection and recorded the actual injection time using a stopwatch. During the injection, the number of patient-reported pain episodes, immediate pain scores, and the number of times the nurse interrupted the injection due to hand fatigue were recorded. The patient's blood pressure and pulse were recorded before, during, and after the injection.
| Study group | Role | What they receive |
|---|---|---|
| Instrument-driven constant-rate injection | Experimental | Drug preparation followed the standard procedure. A fixed team of two nurses, trained according to the study protocol, performed the instrument-driven injection. The nurses, after training, used the syringe pump BeneFusion SP3 (card number: 081787) and set the infusion rate at 2 mL/min according to the drug instructions. Standard procedures were followed for injection site, disinfection, etc. The syringe model and needle gauge were consistent with those used in the manual injection group (control group). During the injection, the number of patient-reported pain episodes and immediate pain scores were recorded. The instrument preparation time was recorded, including the time from "taking the instrument - connecting the power - installing the syringe - setting parameters", as well as the time from "turning off the power - tidying up the instrument" after injection completion. The patient's blood pressure and pulse were recorded before, during, and after the injection. Receives: Other: Instrument-driven constant-rate injection |
| Manual injection | Active comparator | Drug preparation followed the standard procedure. A fixed team of two nurses, trained according to the study protocol, performed manual injection. The nurses, after training, simulated the speed of the machine injection and recorded the actual injection time using a stopwatch. During the injection, the number of patient-reported pain episodes, immediate pain scores, and the number of times the nurse interrupted the injection due to hand fatigue were recorded. The patient's blood pressure and pulse were recorded before, during, and after the injection. Receives: Other: Instrument-driven constant-rate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity score
Measure using the Numerical Rating Scale (NRS, 0-10)
Measured: Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection
Pain intensity score
Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection，Measure using the Numerical Rating Scale (NRS, 0-10)
Measured: Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanting Peng, Bachelor's Degree, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversitySun Yat-sen University, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533526
- Sponsor's protocol ID
- SYSKY-2026-251-02
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small - scale exploratory study focused on internal hypothesis - testing and preliminary mechanism analysis. The data is not intended for external collaboration, as it lacks sufficient generalizability to support broader scientific inferences. All findings are based on aggregated and de - identified results reported in the main publication.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrument-Assisted Constant-Speed Injection Versus Manual Injection on Pain From Large-Volume Subcutaneous Injection of Pertuzumab and Trastuzumab in Breast Cancer: A Randomized, Self-Controlled Study
- ClinicalTrials.gov ID
- NCT07533526
- Acronym / sponsor ID
- SYSKY-2026-251-02
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Pertuzumab and Trastuzumab, Large volume subcutaneous injection, Instrument-driven constant-rate injection / manual injection, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 16 Apr 2026 (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.
Research Background:Subcutaneous injection is an important route of administration in targeted therapy for breast cancer, but injection pain affects patients' treatment experience. Fluctuations in injection speed during traditional manual push may be one of the factors exacerbating pain, whereas machine-driven injection can provide a constant flow rate, theoretically reducing pain; however, high-quality evidence is lacking.
Research Objective:To compare the difference in pain intensity between instrument constant-speed injection and manual injection in breast cancer patients receiving subcutaneous injection of pertuzumab and trastuzumab.
Research Methods:A randomized self-controlled design is used, with data analysis performed using paired t-tests. The study plans to enroll 40 female breast cancer patients. Each patient receives two injection methods across two treatment cycles: instrument constant-speed injection (medical infusion pump, 2 mL/min) and manual injection (a nurse uses a stopwatch to time and simulates the injection pump speed of 2 mL/min). The order of injection methods is randomly assigned by drawing lots (the injection method for the first cycle is randomly drawn, and the method for the second cycle is naturally the alternative method). The primary outcome is the patient's most severe pain during injection, measured immediately after injection using the Numerical Rating Scale (NRS, 0-10). Secondary outcomes include injection site reactions, patient satisfaction, nurse fatigue (Borg CR10 scale), patient preference, and safety indicators.
Research Significance:The results of this study will provide high-level evidence for selecting comfortable and efficient subcutaneous injection techniques in clinical practice, thereby improving patients' treatment experience.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instrument-driven constant-rate injection | Experimental | Other: Instrument-driven constant-rate injectionDrug preparation followed the standard procedure. A fixed team of two nurses, trained according to the study protocol, performed the instrument-driven injection. The nurses, after training, used the syringe pump BeneFusion SP3 (card number: 081787) and set the infusion rate at 2 mL/min according to the drug instructions. Standard procedures were followed for injection site, disinfection, etc. The syringe model and needle gauge were consistent with those used in the manual injection group (control group). During the injection, the number of patient-reported pain episodes and immediate pain scores were recorded. The instrument preparation time was recorded, including the time from "taking the instrument - connecting the power - installing the syringe - setting parameters", as well as the time from "turning off the power - tidying up the instrument" after injection completion. The patient's blood pressure and pulse were recorded before, during, and after the injection. |
| Manual injection | Active comparator | Other: Instrument-driven constant-rate injectionDrug preparation followed the standard procedure. A fixed team of two nurses, trained according to the study protocol, performed manual injection. The nurses, after training, simulated the speed of the machine injection and recorded the actual injection time using a stopwatch. During the injection, the number of patient-reported pain episodes, immediate pain scores, and the number of times the nurse interrupted the injection due to hand fatigue were recorded. The patient's blood pressure and pulse were recorded before, during, and after the injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female breast cancer patients histologically confirmed as HER2-positive.
- Have completed at least one subcutaneous injection of Phesgo, with at least three planned injections remaining.
- No history of acute allergic reactions (e.g., Grade 1-2 allergic reactions) during previous Phesgo injections.
- Aged between 18 and 70 years (inclusive).
- No use of pain medications, pain patches, or pain pumps for pain management within 3 days prior to injection.
Key exclusion criteria (4 listed)
- Presence of any skin diseases or conditions affecting subcutaneous injection (e.g., severe infection or dermatitis at the injection site).
- Simultaneous participation in other clinical trials that may interfere with the results of this study.
- Cognitive impairment or mental illness preventing completion of study questionnaires and assessments.
- Regular use of analgesics.
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 |
|---|---|---|
| Instrument-driven constant-rate injectionDrug preparation followed the standard procedure. A fixed team of two nurses, trained according to the study protocol, performed manual injection. The nurses, after training, simulated the speed of the machine injection and recorded the actual injection time using a stopwatch. During the injection, the number of patient-reported pain episodes, immediate pain scores, and the number of times the nurse interrupted the injection due to hand fatigue were recorded. The patient's blood pressure and pulse were recorded before, during, and after the injection. | Other | Instrument-driven constant-rate injection, Manual injection |
Primary outcome
Pain intensity score
Time frame: Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection
Measure using the Numerical Rating Scale (NRS, 0-10)
Pain intensity score
Time frame: Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection
Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection，Measure using the Numerical Rating Scale (NRS, 0-10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is a small - scale exploratory study focused on internal hypothesis - testing and preliminary mechanism analysis. The data is not intended for external collaboration, as it lacks sufficient generalizability to support broader scientific inferences. All findings are based on aggregated and de - identified results reported in the main publication.
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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.
Yanting Peng, Bachelor's Degree principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sun Yat-sen University principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument-driven constant-rate injection in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 7 inclusion and 4 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 16 Apr 2026. 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?
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?
Contact Yanting Peng, Bachelor's Degree (86+13710350704, 472195985@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity score (time frame: Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection). The study lists 2 primary outcomes in all. 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 16 Apr 2026.