esophageal cancer, gastric cancer, small bowel cancer, colon cancer, pancreatic cancer
Conditions
Interventions
Initial dose of mirogabalin orally twice daily, then titrated at intervals of at least 1 week to a maintenance dose orally twice daily.
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unresectable advanced or recurrent gastrointestinal cancer (gastric cancer, colon cancer, pancreatic cancer, esophageal cancer, small bowel cancer) Histologically diagnosed. 2) Age at the time of registration is 20 years or older. 3) Performance Status (ECOG) is 0-2. 4) Patients who have no history of systemic chemotherapy as first-line therapy. (Patients with a history of preoperative or postoperative chemotherapy may be enrolled if there is no residual cancer after surgery (R0 resection) and the last administration is 180 days or more before the confirmed date of recurrence.) 5) Started first-line therapy with oxaliplatin-containing regimen and is continuing treatment, or is continuing first-line therapy mainly with fluoropyrimidines after stopping oxaliplatin. 6) CIPN pain (including numbness) NRS of 4 or higher at enrollment. 7) Patients who have not used mirogabalin within 28 days before enrollment. 8) Oral intake is possible. 9) Written consent has been obtained from the patient to participate in the study.
Exclusion criteria
Exclusion criteria: 1)Patients diagnosed with diabetic neuropathy. 2)Patients with cervical or lumbar spondylosis causing neuropathic pain. 3)Patients with creatinine clearance (Cockcroft-Gault formula)less than 30 mL/min at enrollment. 4)Women who are pregnant or breast-feeding, who need to continue breast-feeding after starting study drug administration, or who may be pregnant. 5)Patients with a history of hypersensitivity reaction to mirogabalin besilate. 6)Concomitant use of the following drugs: pregabalin, gabapentin, Tricyclic antidepressants: amitriptyline, nortriptyline, imipramine, clomipramine, SNRIs: duloxetine, venlafaxine, milnacipran, Antiepileptic drugs: carbamazepine, sodium valproate, lamotrigine, topiramate, clonazepam, Kampo medicine: goshajinkigan Other: cimetidine, probenecid. 7)Patients who newly added the following drugs or changed the dose (increase or decrease) by 10% or more within 14 days before registration. Opioid analgesics, tramadol, NSAIDs, acetaminophen. 8)Patients who are complicated by psychosis or psychiatric symptoms that interfere with daily life and are judged to be difficult to participate in the study. 9)In addition, those who are judged to be inappropriate as research subjects by the principal investigator or co-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24-hour pain (including numbness) average NRS (Numeric Rating Scale) from the start of mirogabalin administration to 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Rate of improvement in peripheral sensory neuropathy severity (CTCAE ver5.0 Grade) after 3, 6, and 12 weeks from the start of mirogabalin administration as a baseline - Changes in FACT/GOG NTx after 3 weeks, 6 weeks, and 12 weeks from the start of mirogabalin administration - Change in pain (including numbness) NRS from 3 weeks to 12 weeks after the start of mirogabalin administration as a baseline - Changes in PHQ9 after 3 weeks, 6 weeks, and 12 weeks from the start of mirogabalin administration -Percentage of achievement of personalized pain goal (PPG) after 3 weeks, 6 weeks, and 12 weeks from the start of mirogabalin administration - Chemotherapy dose reduction, drug interruption, and discontinuation rate from the start of mirogabalin administration to 12 weeks later - Adverse events (CTCAE ver.5.0) - Percentage reaching maintenance dose of mirogabalin at 3, 6 and 12 weeks | — |
Countries
Japan
Contacts
Public ContactHirokazu Shoji
National Cancer Center Hospital Department of Gastrointestinal Medical Oncology
Outcome results
None listed