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

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

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Peripheral Neuropathy

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Laurids Ø Poulsen, MD, PhD; Phone Number: +45 97666795; Email: laop@rn.dk
• Study Contact Backup: Name: Helena Brøckner, Ba.Sc; Phone Number: +4529702992; Email: hbrack15@student.aau.dk

Study Locations

• Denmark
  • Northern Jutland
    • Aalborg, Northern Jutland, Denmark, 9000
      • Recruiting
      • Aalborg University Hospital
      • Contact: Laurids Østergaard Poulsen, PhD; Phone Number: 97666795; Email: laop@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Carsten Dahl Mørch
• Collaborators: Aalborg University Hospital
• Investigators: Principal Investigator: Laurids Ø Poulsen, MD, PhD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Assessment of nerve fiber excitability
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: N-20190071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is not a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No