Post-Mastectomy Pain Syndrome
Conditions
Interventions
Sponsors
National Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with pathologically diagnosed Stage 1-3 breast cancer after radical surgery 2) Patients undergoing treatment-free follow-up at least 6 months after radical surgery without metastatic recurrence (patients on postoperative endocrine therapy or anti-HER2 therapy are included) 3) Postoperative average pain intensity (NRS) >= 4 over the past 24 hours in the chest, shoulder, or neck on the operated side 4) Age >= 18 years on the date of enrollment 5) ECOG PS 0 or 1 on the date of registration 6) Latest laboratory values within 28 days prior to enrollment (same day of the week 28 days prior to enrollment is acceptable) are Neutrophils >= 1000/mcL, platelets >= 50,000/mcL 7) No change in pain medication* within 7 days prior to enrollment (same day of the week 7 days prior to enrollment is acceptable) 8) Patients who have given their free and voluntary consent in writing to participate in this study
Exclusion criteria
Exclusion criteria: 1) Preoperative chest, shoulder, or neck pain on the operative side 2) Lymphedema in the upper extremity on the operative side 3) Bilateral chest, shoulder, or neck pain 4) Painful comorbidities such as fibromyalgia, inflammatory joint disease, etc. 5) Undergoing chemotherapy (excluding anti-HER2 therapy) or radiotherapy as of the date of registration 6) Has a psychiatric disorder such as severe depression (as determined by the attending physician) 7) Patients with serious complications (as determined by the attending physician) 8) Pregnant or lactating patients 9) Previous acupuncture treatment for PMPS 10) Patients currently enrolled in a clinical trial or a clinical trial affecting this study 11) Other patients deemed by the attending physician to be unsuitable for enrollment in the relevant clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity (NRS) between baseline and week 16. | — |
Countries
Japan
Contacts
Public ContactHiroto Ishiki
National Cancer Center Hospital Department of Palliative Medicine
Outcome results
None listed