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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122362
Enrollment
Unknown
Registered
2026-04-13
Start date
2026-04-13
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Control group:Manual injection method
Experimental group:Instrument constant-speed injection method

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Pain intensity score;

Secondary

MeasureTime frame
Local adverse reactions: induration, itching, subcutaneous hemorrhage, erythema, ecchymosis;Nurse fatigue level;Patient preference;Patient satisfaction;

Countries

China

Contacts

Public ContactPengyanting

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

472195985@qq.com+86 20 81340187

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026