Chemotherapy-induced Peripheral Neuropathy
Conditions
Keywords
Assessment of nerve fiber excitability
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.
Interventions
None listed
Sponsors
Aalborg University Hospital
Carsten Dahl Mørch
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Nerve fiber excitability | The difference between baseline and the 6 months follow-up | The chronaxie and the rheobase to rectangular stimuli, the accommodation to triangular stimuli, and the electrotonus to subthreshold hyperpolarizing pre-pulses for large and small sensory nerves from the excitability measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Quantitative sensory test | The difference between baseline and the 6 months follow-up | The Quantitative sensory test is a reduced version of the German protokol and contains warmth and cold detection thresholds, heat and cold pain thresholds, vibration threshold and perceived intensity to mechanical stimuli. |
| Changed of CTCAE | The difference between baseline and the 6 months follow-up | Common Terminology Criteria for Adverse events scale is a scale from 0 to 5, where 5 is worse. |
| Change of CIPN20. | The difference between baseline and the 6 months follow-up | Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Twenty-Item scale is a 20-item self-report questionnaire. Items are scored 1-4 with 1 representing not at all and 4 very much. Scores are then linearly converted to a 0-100 scale where 100 is worse. |
Countries
Denmark
Contacts
Primary ContactLaurids Ø Poulsen, MD, PhD
Backup ContactHelena Brøckner, Ba.Sc
Outcome results
None listed