JRCT ID: jRCT1071250142
Registered date:16/03/2026
Study of Mirogabalin and pregabalin to Improve Limb nEuropathy
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Breast cancer |
| Date of first enrollment | 16/03/2026 |
| Target sample size | 48 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Pregabalin or mirogabalin will be administered as therapeutic agents for peripheral neuropathy. |
Outcome(s)
| Primary Outcome | NRS (Numerical Rating Scale) |
|---|---|
| Secondary Outcome | CTCAE ver6.0, PRO-CTCAE |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1)Patients who have received perioperative chemotherapy for breast cancer and have developed chemotherapy-induced peripheral neuropathy (CIPN). 2) Patients who are able to complete a patient diary and questionnaire survey. 3) Patients aged between 18 and 80 years at the time of obtaining informed consent. 4) Patients who have provided written informed consent to participate in the study. |
| Exclude criteria | 1) Patients who have peripheral neuropathy prior to the initiation of chemotherapy. 2) Patients who are currently taking pregabalin or mirogabalin besilate. 3) Patients who are pregnant or breastfeeding. 4) Patients who are currently participating in another clinical trial or clinical study. 5) Patients whom the principal investigator or subinvestigator deems inappropriate for inclusion in the study. |
Related Information
| Primary Sponsor | Kuba Sayaka |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Sayaka Kuba |
| Address | 1-7-1, Sakamoto-machi, Nagasaki city, Nagasaki prefecture Nagasaki Japan 8528501 |
| Telephone | +81-958197316 |
| skuba@nagasaki-u.ac.jp | |
| Affiliation | Nagasaki University Hospital |
| Scientific contact | |
| Name | Sayaka Kuba |
| Address | 1-7-1, Sakamoto-machi, Nagasaki city, Nagasaki prefecture Nagasaki Japan 8528501 |
| Telephone | +81-958197316 |
| skuba@nagasaki-u.ac.jp | |
| Affiliation | Nagasaki University Hospital |