A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

— PacTox  

Official title:

A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237194
• Other study ID #: N-20190071
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2022
• Source: Aalborg University
• Contact: Laurids Ø Poulsen, MD, PhD
• Phone: +45 97666795
• Email: laop[@]rn.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	Northern Jutland

Sponsors (2)

Lead Sponsor	Collaborator
Carsten Dahl Mørch	Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Nerve fiber excitability	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.	The difference between baseline and the 6 months follow-up
Secondary	Change of Quantitative sensory test	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.	The difference between baseline and the 6 months follow-up
Secondary	Changed of CTCAE	Common Terminology Criteria for Adverse events scale is a scale from 0 to 5, where 5 is worse.	The difference between baseline and the 6 months follow-up
Secondary	Change of CIPN20.	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.	The difference between baseline and the 6 months follow-up