A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
PacTox
1 other identifier
observational
20
1 country
1
Brief Summary
To assess the impact of Paclitaxel treatment on the nerve excitability of the small and large nerve fibers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 23, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedAugust 24, 2022
August 1, 2022
3.3 years
January 15, 2020
August 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change of Quantitative sensory test
The difference between baseline and the 6 months follow-up
Changed of CTCAE
The difference between baseline and the 6 months follow-up
Change of CIPN20.
The difference between baseline and the 6 months follow-up
Eligibility Criteria
Breast cancer patients receiving adjuvant chemotherapy, consisting of 3 cycles of Epirubicin and Cyclophosphamide (EC), followed by 3 cycles of Paclitaxel (9 Paclitaxel infusions).
You may qualify if:
- \> 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carsten Dahl Mørchlead
- Aalborg University Hospitalcollaborator
Study Sites (1)
Aalborg University Hospital
Aalborg, Northern Jutland, 9000, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Laurids Ø Poulsen, MD, PhD
Aalborg University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 23, 2020
Study Start
September 1, 2020
Primary Completion
December 30, 2023
Study Completion
June 30, 2024
Last Updated
August 24, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
There is not a plan to make IPD available