Neuropathic pain associated with post-breast surgery pain syndrome
Conditions
Interventions
This study aims to explore the efficacy and safety of mirogabalin in patients with post breast surgery pain syndrome. Eligible patients will be randomized into two groups: a mirogabalin add-on therapy
Sponsors
Tane Kaori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who have undergone breast surgery for breast cancer within 365 days prior to enrollment. 2.Patients who are receiving analgesic treatment (oral or transdermal) for postoperative pain following breast surgery. 3.Patients with a DN4 score of 4 out of 10 or higher and who have neuropathic pain consistent with the nerve distribution of the breast surgery site. 4.Patients whose NRS score for the pain confirmed in Item 3 is 4 or higher. 5.Patients who are 18 years of age or older at the time of informed consent. 6.Patients who are able to provide written informed consent of their own free will. 7.Patients who can understand the study procedures and appropriately respond to Japanese-language questions in written or electronic form (electronic patient-reported outcome: ePRO) without assistance.
Exclusion criteria
Exclusion criteria: 1.Patients who are hospitalized. 2.Patients whose most recent creatinine clearance (CLcr) is less than 30 mL/min. 3.Patients with a history of hypersensitivity to mirogabalin, pregabalin, or gabapentin. 4.Patients with severe hepatic, renal, or cardiac disease. 5.Patients who have taken mirogabalin within 28 days prior to obtaining informed consent. 6.Patients who are pregnant or may be pregnant at the time of consent, patients who are breastfeeding at the time of consent, or patients who intend to become pregnant within 6 months after providing consent. 7.Patients who are participating in, or are scheduled to participate in, another interventional study at the time of enrollment. 8.Patients with chemotherapy-induced peripheral neuropathy or radiation-induced neuropathic pain for whom the efficacy assessment would be difficult. 9.Patients who are otherwise judged by the investigator to be unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain score (NRS) from baseline to Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Daily changes in pain score (NRS) at study completion/discontinuation, weekly assessments, and weekly assessments from the date of surgery 2. Responder rates (>=30% and >=50% improvement in pain NRS, and NRS = 7) | — |
Contacts
Public ContactKaori Tane
Hyogo Cancer Center
Outcome results
None listed