Chemotherapy-induced Peripheral NeuropathyPacToxNCT04237194
A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Carsten Dahl Mørch at 1 site in Denmark.
Trial summary
To assess the impact of Paclitaxel treatment on the nerve excitability of the small and large nerve fibers Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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).
Who may be able to join
- > 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
Who cannot join
- Previously neoadjuvant treatment with chemotherapy
- Receives prophylactic bone marrow stimulants
- HIV
- Diabetes mellitus
- Opioid requirement
- Symptomatic neurosensory disorders
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, Northern Jutland, 9000
Laurids Østergaard Poulsen, PhD, 97666795, laop@rn.dk
About this study
To assess the impact of Paclitaxel treatment on the nerve excitability of the small and large nerve fibers
Read the 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.
- Keywords
- Assessment of nerve fiber excitability
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The difference between baseline and the 6 months follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: The difference between baseline and the 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Sep 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carsten Dahl Mørch
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Carsten Dahl Mørch, Aalborg University
- Investigators
- Laurids Ø Poulsen, MD, PhD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237194
- Sponsor's protocol ID
- N-20190071
- Acronym
- PacTox
- Status last verified
- Aug 2022
- First submitted
- 15 Jan 2020
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04237194
- Acronym / sponsor ID
- PacTox / N-20190071
- Keywords
- Assessment of nerve fiber excitability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Carsten Dahl MørchUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- > 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
Key exclusion criteria (11 listed)
- Previously neoadjuvant treatment with chemotherapy
- Receives prophylactic bone marrow stimulants
- HIV
- Diabetes mellitus
- Opioid requirement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Nerve fiber excitability
Time frame: 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.
3 secondary outcomes
Change of Quantitative sensory test
Time frame: The difference between baseline and the 6 months follow-up
Changed of CTCAE
Time frame: The difference between baseline and the 6 months follow-up
Change of CIPN20.
Time frame: The difference between baseline and the 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurids Ø Poulsen, MD, PhD principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Carsten Dahl Mørch at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurids Ø Poulsen, MD, PhD (+45 97666795, laop@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Nerve fiber excitability (time frame: The difference between baseline and the 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.