Clinical trial NCT04237194: A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
Official title: A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Assessment of nerve fiber excitability
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2020-01-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients receiving adjuvant chemotherapy, consisting of 3 cycles of Epirubicin and Cyclophosphamide (EC), followed by 3 cycles of Paclitaxel (9 Paclitaxel infusions).

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. \> 18 years
2. Histopathologically verified breast cancer
3. Performance Status according to WHO/ECOG (PS) 0-2
4. Candidate for adjuvant standard treatment with EC and Paclitaxel
5. Not previously treated with chemotherapeutic agents
6. Neurological examination without pathological findings
7. Willingness to voluntarily sign an informed consent

Exclusion Criteria:

1. Previously neoadjuvant treatment with chemotherapy
2. Receives prophylactic bone marrow stimulants
3. HIV
4. Diabetes mellitus
5. Opioid requirement
6. Symptomatic neurosensory disorders
7. Neurological diseases, such as sclerosis and epilepsy
8. Alcohol abuse
9. "Palmar-plantar erythrodysesthesia syndrome" / ulceration of hands or feet
10. Cannot understand written or oral information in Danish
11. Inability to cooperate

Primary outcomes:
measure: Change of Nerve fiber excitability
timeFrame: The difference between baseline and the 6 months follow-up
Secondary outcomes:
measure: Change of Quantitative sensory test
timeFrame: The difference between baseline and the 6 months follow-up
measure: Changed of CTCAE
timeFrame: The difference between baseline and the 6 months follow-up
measure: Change of CIPN20.
timeFrame: The difference between baseline and the 6 months follow-up
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Northern Jutland
Study officials:
affiliation: Aalborg University Hospital
name: Laurids Ø Poulsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: