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
Summary
NIH registered a clinical trial (NCT07533526) on ClinicalTrials.gov comparing instrument-assisted constant-speed injection versus manual injection for subcutaneous administration of pertuzumab and trastuzumab in breast cancer patients. The randomized, self-controlled study plans to enroll 40 female patients, with each receiving both injection methods across two treatment cycles. Pain intensity will be measured using the Numerical Rating Scale immediately after injection.
What changed
NIH registered a new clinical trial on ClinicalTrials.gov (NCT07533526) titled 'Effects of Instrument-Assisted Constant-Speed Injection Versus Manual Injection on Pain From Large-Volume Subcutaneous Injection of Pertuzumab and Trastuzumab in Breast Cancer.' The study uses a randomized, self-controlled design with 40 female breast cancer patients, each receiving both injection methods across two treatment cycles. Instrument-assisted injection uses a medical infusion pump at 2 mL/min while manual injection simulates the same rate. Primary outcome is pain intensity measured via Numerical Rating Scale (0-10) immediately after injection.
Affected parties include pharmaceutical companies marketing pertuzumab and trastuzumab, and healthcare providers administering subcutaneous injections. The study may inform clinical practice regarding injection technique preferences for improving patient comfort during targeted breast cancer therapy. This is an informational registration entry on ClinicalTrials.gov and does not impose compliance obligations on regulated entities.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
N/A NCT07533526 Kind: NA Apr 16, 2026
Abstract
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 satisf...
Conditions: Breast Cancer
Interventions: Instrument-driven constant-rate injection
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