Pain Associated with Subcutaneous Injection
Conditions
Interventions
Control group:Application of Petroleum Jelly Ointment Prior to Subcutaneous Injection
Experimental group:Application of Compound Lidocaine Cream Prior to Subcutaneous Injection
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Female patients with histologically confirmed HER2-positive early breast cancer (IHC 3+ or FISH-positive), aged 18–70 years, who are expected to complete at least 3 cycles (21 days per cycle) of dual-target therapy and have already received at least one subcutaneous injection of dual-target agents. 2.Completion of all neoadjuvant chemotherapy and surgery. Adjuvant radiotherapy may be planned or ongoing at the time of study enrollment, and adjuvant hormone therapy is permitted during the study period. 3.No evidence of residual disease, local recurrence, or metastatic disease after completion of surgery and chemotherapy. 4.Intact skin and adequate limb function at the planned subcutaneous injection site. 5.Normal bone marrow hematopoietic function prior to chemotherapy (WBC > 3.5 × 10?/L, ANC > 1.8 × 10?/L, RBC > 3.5 × 10?/L, PLT > 100 × 10?/L, Hb > 90 g/L). 6.No severe cardiac, hepatic, or renal dysfunction (LVEF > 55% by two-dimensional echocardiography; ALT and AST = 70. 9.Signed written informed consent approved by the ethics committee, with commitment to complete treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Use of strong analgesic medications for prophylaxis within 48 hours prior to enrollment. 2. Patients with a history of malignancy other than cured basal cell carcinoma or cervical carcinoma in situ within the past five years, or patients with stage IV breast cancer. 3. Participation in other interventional clinical trials or use of investigational drugs within 30 days prior to enrollment. 4. Presence of uncontrolled pulmonary disease, severe infection, active gastrointestinal ulcers requiring treatment, active liver disease, severe uncontrolled diabetes mellitus, connective tissue disease, or bone marrow suppression, rendering the patient unable to tolerate the relevant treatment. 5. History of severe cardiovascular or cerebrovascular disease within six months (e.g., unstable angina, chronic heart failure, uncontrolled hypertension, myocardial infarction, or cerebrovascular accident). 6. Chemotherapy-induced peripheral neuropathy = grade 2 (CTCAE v5.0) or allodynia. 7. Coagulation dysfunction (INR >1.5 or APTT >1.5 times the upper limit of normal) or long-term use of glucocorticoids. 8. Known allergy or hypersensitivity to any of the study drugs or dressings. 9. Pregnancy, lactation, or women of childbearing potential who refuse to use highly effective contraception during the study period and for 8 weeks after study completion. 10. Presence of psychiatric disorders, cognitive impairment, inability to comprehend the study plan and potential side effects, or inability to complete the study procedures and follow-up (systematic assessment required prior to enrollment). 11. Lack of personal freedom or independent legal capacity. 12. Any other condition or symptom deemed by the investigator as rendering the patient unsuitable for study participation, or for whom the study medication may pose a health risk or interfere with the assessment of adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of pain score (VAS score) differences during dual-target subcutaneous injection.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of local or systemic adverse events during each treatment cycle.;Comparison of changes in pain scores (VAS scores) from the time of dual-target subcutaneous injection through the observation period.;Patient medication satisfaction (assessed via the TSQM-9 questionnaire) and treatment preference tendency.; | — |
Countries
China
Contacts
Public ContactWang Jue
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed