MICHEL Study

JRCT ID: jRCTs031220001

Registered date:04/04/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Primary breast cancer
• Date of first enrollment: 12/04/2022
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Administration of Mirogabalin twice a day.
At the first week, mirogabalin is administrated in d ose of 5 mg twice a day .
At the second week, mirogabalin is administrated i n dose of 10 mg twice a day if the effect is insuffici ent. At the third week, dose of mirogabalin is incre ased to 15 mg twice a day if the effect is insufficient.

Outcome(s)

• Primary Outcome: Amount of the change of peripheral neuropathy intensity(Visual Analogue Scale) from the enrollment to the end of the study

Secondary Outcome

(1)Amount of the change of Patient Neurotoxicity Questionnair of the upper and lower limbs from th e enrollment to the end of the study
(2)Amount of the change of FACT/COG-NTX from the enrollment to the end of the study
(3)Amount of the change of PainVision score of th e upper and lower limbs from the enrollment to th e end of the study
(4)Amount of the change of manipulation time of O'Connor Finger Dexterity Test from the enrollmen t to the end of the study
(5)Chemotherapy completion rate and reduction rate
(6)Subjective symptoms, somnolence, nausea, diz ziness and peripheral edema (PRO-CTCAE&trade J apanese)
(7)Questionnaire survey about mirogabalin
(8)Completion rate of mirogabalin
(9)Continuity status of mirogabalin after the study
(10)Adverse events of CTCAE ver 5.0 grading scal e, except for which are not clearly relate to miroga balin

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

(1)Patients aged between 18 and 75 at the time o f consent
(2)Patients with stage 1- 3C primary breast cancer
(3)Patients with Grade 2 or higher peripheral neuropathy induced paclitaxel based on the NCI C ommon Toxicity Criteria for Adverse Events (CTCAE) ver 5.0 grading scale during or after receiving p aclitaxel in perioperative chemotherapy for primar y breast cancer
(4)Eastern Cooperative Oncology Group Performa nce status 0 or 1
(5)Patients who have agreed in writing to particip ate in this study after understanding this study an d who can adequately answer patient questionnaires.

Exclude criteria

(1)Patients with peripheral neuropathy in the upp er or lower limbs at the time of perioperative chem otherapy
(2)Patients who recieved other chemotherapy whi ch induce CIPN
(3)Patients with injury or inflammatory diseases o n the skin of the forearms or lower legs
(4)Patients with artificial cardiac pacemaker or ot her electronic implant
(5)Patients whose estimated glemerular filtration r ate is under 60 mL/min/1.73 square metre
(6)Patients whose AST or ALT is over 100 U/L
(7)Patients who recieving pregabalin, provenesid, cimetidine and lorazepam
(8)Patients with a history of hypersensitivity to mir ogabalin and similar material of mirogabalin
(9)Patients with uncontrolled diabetes
(10)Other patients that the research doctor deem s inappropriate

Related Information

• Primary Sponsor: Bando Hiroko
• Source(s) of Monetary Support: University of Tsukuba Hospital