A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy (PacTox)

  • End date
    Jun 30, 2024
  • participants needed
  • sponsor
    Carsten Dahl Mørch
Updated on 18 September 2022
breast cancer
peripheral neuropathy
antineoplastic drugs
diagnostic method
breast cancer 3


To assess the impact of Paclitaxel treatment on the nerve excitability of the small and large nerve fibers


Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of many chemotherapeutic agents, especially antineoplastic agents. To limit the nerve damages, early detection and management of CIPN is crucial and leaves an urgent demand for new diagnostic tools. Perception threshold tracking has enabled assessments of nerve excitability tests of both small and large sensory nerves and may be used to assess CIPN at early stages. The purpose of this study is to examine whether a new nerve excitability test can detect changes in the membrane properties of the small and large nerve fibers during chemotherapy treatment.

In this study nerve excitability tests will be performed with 2 different electrodes using a novel perception threshold tracking technique to assess the Nerve excitability of small and large fibers. Further quantitative sensory tests (QST) will be performed to estimate the vibration threshold, warm and cool perception thresholds, heat and cold pain thresholds, and perceived intensity to static mechanic stimulations will be assessed. Symptoms of CIPN will be assessed using the Common Terminology Criteria for Adverse events scale and a Quality of Life Questionnaire CIPN twenty-item scale.

Condition Chemotherapy-induced Peripheral Neuropathy
Clinical Study IdentifierNCT04237194
SponsorCarsten Dahl Mørch
Last Modified on18 September 2022


Yes No Not Sure

Inclusion Criteria

> 18 years
Histopathologically verified breast cancer
Performance Status according to WHO/ECOG (PS) 0-2
Candidate for adjuvant standard treatment with EC and Paclitaxel
Not previously treated with chemotherapeutic agents
Neurological examination without pathological findings
Willingness to voluntarily sign an informed consent

Exclusion Criteria

Previously neoadjuvant treatment with chemotherapy
Receives prophylactic bone marrow stimulants
Diabetes mellitus
Opioid requirement
Symptomatic neurosensory disorders
Neurological diseases, such as sclerosis and epilepsy
Alcohol abuse
Palmar-plantar erythrodysesthesia syndrome" / ulceration of hands or feet
Cannot understand written or oral information in Danish
Inability to cooperate
Clear my responses

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