{
  "abstract": "Background/Objectives Chemotherapy-induced peripheral neuropathy (CIPN) can result in early chemotherapy cessation and chronic, disabling neuropathic symptoms. Duloxetine has previously demonstrated efficacy for symptom relief, however evidence is limited to painful CIPN, which is a phenotype experienced by less than half of all CIPN patients. Furthermore, previous studies have not explored neurophysiological mechanisms underlying symptom relief associated with duloxetine. This trial assessed whether duloxetine reduces overall neuropathic symptom burden in patients with CIPN and its impact on neurophysiological parameters.Methods A randomized, placebo-controlled crossover trial was conducted, with patients randomized to receive either 8 weeks of duloxetine followed by 8 weeks of placebo, or the reverse. Eligibility criteria included daily CIPN symptoms for at least 3 months following chemotherapy. The primary outcome measure was change in patient-reported neuropathy via the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-NTx) questionnaire. Secondary outcomes were change in objective neurophysiological parameters via the Total Neuropathy Score (TNS) and sural amplitude.Results 20 patients completed the trial, of which 35% reported painful CIPN. While both duloxetine and placebo demonstrated reduced FACT-GOG-NTx score after 8 weeks, only the mean score change in the placebo group exceeded the threshold of 2.8 for clinical importance (duloxetine mean score change; -1.41; 95% CI -3.65 to 0.838 vs. placebo -3.27; 95% CI -5.11 to -1.43; p=0.189). No significant difference in TNS score or sural amplitude were observed between duloxetine and placebo groups.Conclusions In this small cohort, duloxetine did not demonstrate efficacy in improving symptom burden or neurophysiological parameters in CIPN.",
  "authors": [
    {
      "affiliations": [
        "Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia",
        "Royal Prince Alfred Hospital, Sydney, NSW, Australia"
      ],
      "name": "Jennifer Vu"
    },
    {
      "affiliations": [
        "The University of New South Wales, Sydney, NSW, Australia"
      ],
      "name": "Eva Battaglini"
    },
    {
      "affiliations": [
        "Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia"
      ],
      "name": "Tiffany Li"
    },
    {
      "affiliations": [
        "Cancer Care Services, Royal Brisbane and Women’s Hospital, Brisbane, QLD, Australia",
        "Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia"
      ],
      "name": "David Wyld"
    },
    {
      "affiliations": [
        "Department of Neurology, Royal Brisbane and Women’s Hospital, Brisbane, QLD, Australia"
      ],
      "name": "Robert Henderson"
    },
    {
      "affiliations": [
        "Sydney Adventist Hospital, Sydney, NSW, Australia",
        "School of Medicine and Psychology, The Australian National University, Canberra, ACT, Australia"
      ],
      "name": "Gavin Marx"
    },
    {
      "affiliations": [
        "The University of New South Wales, Sydney, NSW, Australia"
      ],
      "name": "Arun Krishnan"
    },
    {
      "affiliations": [
        "The University of New South Wales, Sydney, NSW, Australia",
        "Prince of Wales Hospital, Sydney, NSW, Australia"
      ],
      "name": "David Goldstein"
    },
    {
      "affiliations": [
        "Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia"
      ],
      "name": "Susanna B Park"
    }
  ],
  "title": "CS18 Effect of duloxetine on neuropathic symptom burden and objective neurophysiological parameters in chemotherapy-induced peripheral neuropathy: a crossover randomised controlled trial",
  "uid": "2fe42ab0-d3c1-505e-ad03-b3d5e51866e2"
}