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

NCT07533526 | Not Yet Recruiting DMC

• 1 other identifier: SYSKY-2026-251-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Pertuzumab and Trastuzumab; Large volume subcutaneous injection; Instrument-driven constant-rate injection / manual injection; Pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity score

  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

  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

Study Arms (2)

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.

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.

Other: Instrument-driven constant-rate injection

Interventions

Instrument-driven constant-rate injection OTHER

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.

Instrument-driven constant-rate injection; Manual injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanting Peng, Bachelor's Degree

CONTACT

86+13710350704; 472195985@qq.com

Yunfang Yu, Doctoral Degree / Ph.D.

CONTACT

86+18928926137; 18324208@QQ.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)