A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy

• Conditions: Chemotherapy-induced Peripheral Neuropathy

• Registration Number: NCT04237194
• Lead Sponsor: Carsten Dahl Mørch

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.

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-23
• Study Start: 2020-09-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Northern Jutland, Denmark