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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    20
  • sponsor
    Carsten Dahl Mørch
Updated on 18 September 2022
paclitaxel
cancer
breast cancer
peripheral neuropathy
antineoplastic drugs
diagnostic method
breast cancer 3

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.

Details
Condition Chemotherapy-induced Peripheral Neuropathy
Clinical Study IdentifierNCT04237194
SponsorCarsten Dahl Mørch
Last Modified on18 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Previously neoadjuvant treatment with chemotherapy
Receives prophylactic bone marrow stimulants
HIV
Diabetes mellitus
Opioid requirement
Symptomatic neurosensory disorders
Neurological diseases, such as sclerosis and epilepsy
Alcohol abuse
Palmar-plantar erythrodysesthesia syndrome" / ulceration of hands or feet
Cannot understand written or oral information in Danish
Inability to cooperate
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note