Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors
NCT ID: NCT06711978
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2024-12-01
2025-06-30
Brief Summary
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There will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN).
Participants will:
* Take drug duloxetine or a mirogabalin every day for 4 weeks.
* Visit the clinic once every 2 weeks for checkups and tests
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mirogabalin Group
Duloxetine
Participants will receive Duloxetine at a dose of once daily for 4 weeks to manage CIPN pain.
Duloxetine Group
Mirogabalin
Participants will receive Mirogabalin at a dose of twice daily for 4 weeks to manage CIPN pain.
Interventions
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Mirogabalin
Participants will receive Mirogabalin at a dose of twice daily for 4 weeks to manage CIPN pain.
Duloxetine
Participants will receive Duloxetine at a dose of once daily for 4 weeks to manage CIPN pain.
Eligibility Criteria
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Inclusion Criteria
* Peripheral, symmetrical pain in both feet occurring within 12 weeks of initiating chemotherapy with taxane or platinum agents (or their combination).
* Patients experiencing at least grade 2 peripheral neuropathy as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with an average pain intensity of 4 or higher on the Numerical Rating Scale (NRS) during the past week, following the completion of chemotherapy.
* Concurrent use of selected analgesics (acetaminophen, nonsteroidal anti-inflammatory drugs \[NSAIDs\]) is permitted if the following conditions are met:
1. No new analgesics are introduced.
2. Current analgesics are not discontinued.
3. The total weekly 24-hour dose of analgesics does not vary by more than 10% during the 2 weeks prior to enrollment.
* Ongoing treatment for peripheral neuropathy or neuropathic pain must be discontinued at least 7 days before randomization
Exclusion Criteria
* Patients with significant psychiatric disorders, such as severe depression, bipolar disorder, or suicidal ideation.
* Pregnant or breastfeeding patients.
* Patients with a history of prior treatment with other neurotoxic chemotherapeutic agents.
* Patients with renal impairment (creatinine clearance \< 30 mL/min) or hepatic dysfunction.
* Patients with planned surgical procedures within 4 weeks of enrollment.
19 Years
ALL
No
Sponsors
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Pusan National University Yangsan Hospital
OTHER
Responsible Party
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Locations
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Yangsan Pusan National University Hospital
Mulgeum, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Sundar R, Bandla A, Tan SS, Liao LD, Kumarakulasinghe NB, Jeyasekharan AD, Ow SG, Ho J, Tan DS, Lim JS, Vijayan J, Therimadasamy AK, Hairom Z, Ang E, Ang S, Thakor NV, Lee SC, Wilder-Smith EP. Limb Hypothermia for Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Study. Front Oncol. 2017 Jan 10;6:274. doi: 10.3389/fonc.2016.00274. eCollection 2016.
Misawa S, Denda T, Kodama S, Suzuki T, Naito Y, Kogawa T, Takada M, Suichi T, Shiosakai K, Kuwabara S; MiroCIP study group. Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study). BMC Cancer. 2023 Nov 11;23(1):1098. doi: 10.1186/s12885-023-11560-4.
Jordan B, Jahn F, Sauer S, Jordan K. Prevention and Management of Chemotherapy-Induced Polyneuropathy. Breast Care (Basel). 2019 Apr;14(2):79-84. doi: 10.1159/000499599. Epub 2019 Apr 10.
Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
Hertz DL, Childs DS, Park SB, Faithfull S, Ke Y, Ali NT, McGlown SM, Chan A, Grech LB, Loprinzi CL, Ruddy KJ, Lustberg M. Patient-centric decision framework for treatment alterations in patients with Chemotherapy-induced Peripheral Neuropathy (CIPN). Cancer Treat Rev. 2021 Sep;99:102241. doi: 10.1016/j.ctrv.2021.102241. Epub 2021 Jun 9.
Loprinzi CL, Lacchetti C, Bleeker J, Cavaletti G, Chauhan C, Hertz DL, Kelley MR, Lavino A, Lustberg MB, Paice JA, Schneider BP, Lavoie Smith EM, Smith ML, Smith TJ, Wagner-Johnston N, Hershman DL. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: ASCO Guideline Update. J Clin Oncol. 2020 Oct 1;38(28):3325-3348. doi: 10.1200/JCO.20.01399. Epub 2020 Jul 14.
Other Identifiers
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11-2024-072
Identifier Type: -
Identifier Source: org_study_id