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

Обзор

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.

Вмешательства

• Другое 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 pul

Первичные конечные точки

• Pain intensity score [Срок оценки: Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection]
• Pain intensity score [Срок оценки: Assess immediately after injection, and at 30 minutes, 24 hours, and 48 hours after injection]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT07533526 · SYSKY-2026-251-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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