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

April 9, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yanting Peng, Bachelor's Degree
  • Phone Number: 86+13710350704
  • Email: 472195985@qq.com

Study Contact Backup

  • Name: Yunfang Yu, Doctoral Degree / Ph.D.
  • Phone Number: 86+18928926137
  • Email: 18324208@QQ.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Yanting Peng, Bachelor's Degree

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

Description

Inclusion Criteria:

  1. Female breast cancer patients histologically confirmed as HER2-positive.
  2. Have completed at least one subcutaneous injection of Phesgo, with at least three planned injections remaining.
  3. No history of acute allergic reactions (e.g., Grade 1-2 allergic reactions) during previous Phesgo injections.
  4. Aged between 18 and 70 years (inclusive).
  5. No use of pain medications, pain patches, or pain pumps for pain management within 3 days prior to injection.
  6. Normal activity level (ECOG score 0-2), no limb paralysis, and able to clearly express personal feelings.
  7. Signed informed consent form and voluntarily agreed to participate in this study.

Exclusion Criteria:

  1. Presence of any skin diseases or conditions affecting subcutaneous injection (e.g., severe infection or dermatitis at the injection site).
  2. Simultaneous participation in other clinical trials that may interfere with the results of this study.
  3. Cognitive impairment or mental illness preventing completion of study questionnaires and assessments.
  4. Regular use of analgesics.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Instrument-driven constant-rate injection
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.
Other: Instrument-driven constant-rate injection
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.
Active Comparator: Manual injection
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.
Other: Instrument-driven constant-rate injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection
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)
Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection

Collaborators and Investigators

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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Yanting Peng, Bachelor's Degree, Sun Yat-sen Memorial Hospital of Sun Yat-sen University
  • Principal Investigator: Sun Yat-sen University, Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

April 20, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2026-251-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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