None listed
Conditions
Interventions
Drug : Group D (Duloxetine Monotherapy)
- Initial dose: Duloxetine 30 mg once daily at bedtime (qd hs) (Total daily dose: 30 mg)
- Titration: Dose may be increased or decreased at the investigator’s d
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged between 20 and 80 years. 2. Patients diagnosed with colorectal, anal, or gastric cancer who developed oxaliplatin-induced peripheral neuropathy (OIPN) while receiving XELOX (capecitabine, oxaliplatin) or FOLFOX (leucovorin, 5-FU, oxaliplatin) chemotherapy for postoperative recurrence prevention. 3. Patients diagnosed with OIPN of Grade 2 or higher according to CTCAE version 5.0. 4. Patients with a Numerical Rating Scale (NRS, 0–10) pain score of 4 or higher. 5. Patients who will not alter their cancer treatment plan during the study period. 6. Patients who were taking pregabalin or gabapentin before providing consent must undergo a 2-week washout period before enrollment. 7. Pregabalin, gabapentin, carbamazepine, and lorazepam are prohibited during the study period. 8. Opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and acetaminophen may be used only if they were administered before enrollment, and their dosage and route of administration remain unchanged throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Patients with a creatinine clearance of less than 30 mL/min. 2. Patients who have taken mirogabalin or duloxetine within 28 days prior to consent. 3. Patients with a history of allergy or other adverse reactions to the study drugs. 4. Patients with severe hepatic, renal, or cardiac disease. 5. Patients with uncontrolled hypertension (e.g., systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg). 6. Patients requiring concomitant use of tricyclic antidepressants (TCA) or monoamine oxidase (MAO) inhibitors. 7. Patients with uncontrolled epilepsy or seizure disorders. 8. Patients with psychiatric disorders. 9. Patients who are pregnant, have the potential to become pregnant at the time of consent, or are planning to conceive within 6 months after consent. 10. Patients who are currently participating or planning to participate in another interventional study at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CTCAE version 5.0 Grade | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep disturbance (0 = "no sleep disturbance" to 10 = "completely disrupted sleep due to pain");Cases of dose reduction, discontinuation, or withdrawal of study medication during the study period;Cases of dose reduction, discontinuation, or withdrawal of chemotherapy during the study period;Adverse events of special interest (dizziness, nausea, vomiting, edema, drowsiness);Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity;Korean Neuropathic Pain Questionnaire, KNPQ;Quality of Life Questionnaire – Chemotherapy-Induced Peripheral Neuropathy 20;Pain improvement (Numerical Rating Scale, NRS, 0 = "no pain" to 10 = "worst pain");Tingling sense severity (0 = "no tingling" to 10 = "worst tingling") | — |
Countries
Korea, Republic of
Contacts
Public ContactEun Joo Choi
Seoul National University Bundang Hospital
Outcome results
None listed