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

Overview

To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN). 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

Interventions

• Drug Mirogabalin
  Participants will receive Mirogabalin at a dose of twice daily for 4 weeks to manage CIPN pain.
• Drug Duloxetine
  Participants will receive Duloxetine at a dose of once daily for 4 weeks to manage CIPN pain.

Primary outcome measures

• Brief Pain Inventory-Short Form (BPI-SF) [Time frame: From enrollment to the end of treatment at 4 weeks]

Secondary outcome measures (7)

• NCI-CTCAE v5.0 [Time frame: From enrollment to the end of treatment at 4 weeks.]
• EORTC-QLQ-CIPN20 [Time frame: From enrollment to the end of treatment at 4 weeks.]
• EORTC QLQ-C30 [Time frame: From enrollment to the end of treatment at 4 weeks.]
• Korean neuropathic pain questionnaire neuropathic pain questionnaire(KPNQ) [Time frame: From enrollment to the end of treatment at 4 weeks.]
• sural SNAP amplitude [Time frame: At Baseline]
• peroneal cMAP amplitude [Time frame: At Baseline]
• Medication compliance & ADRs [Time frame: From enrollment to the end of treatment at 4 weeks]

Eligibility criteria

Inclusion criteria

• Cancer survivors aged 19 years or older.
• 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:

• No new analgesics are introduced.
• Current analgesics are not discontinued.
• 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 a prior diagnosis of peripheral neuropathy due to diabetes, trauma, alcohol abuse, compression, or other causes, or those with a previously diagnosed central nervous system disorder. (Patients with pre-existing diabetes or thyroid disease who had no symptoms of peripheral neuropathy, such as numbness or tingling in the hands or feet, before chemotherapy may be included.)
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Yangsan Pusan National University Hospital — Mulgeum

Publications

• 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. PMID 28119855
• 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. PMID 37951905
• 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. PMID 31798378
• 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. PMID 25261162
• 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. PMID 34174668
• 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 2 PMID 32663120

Identifiers

NCT: NCT06711978 · 11-2024-072

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗