Clinical trial NCT06711978: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CIPN
CIPN - Chemotherapy-Induced Peripheral Neuropathy
CIPN in Adjuvant Breast Cancer Patients
Duloxetine
Mirogabalin
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


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:

  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 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.

Primary outcomes:
measure: Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: NCI-CTCAE v5.0
timeFrame: From enrollment to the end of treatment at 4 weeks.
measure: EORTC-QLQ-CIPN20
timeFrame: From enrollment to the end of treatment at 4 weeks.
measure: EORTC QLQ-C30
timeFrame: From enrollment to the end of treatment at 4 weeks.
measure: Korean neuropathic pain questionnaire neuropathic pain questionnaire(KPNQ)
timeFrame: From enrollment to the end of treatment at 4 weeks.
measure: sural SNAP amplitude
timeFrame: At Baseline
measure: peroneal cMAP amplitude
timeFrame: At Baseline
measure: Medication compliance & ADRs
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Mulgeum
country: Korea, Republic of
facility: Yangsan Pusan National University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.