Chemotherapy-induced Peripheral NeuropathyNCT06430814
Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by University of Southern Denmark at 3 sites in Denmark.
Trial summary
Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy. 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
- 188 participants
- Where
- 3 sitesDenmark
- Study dates
- 10 Oct 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across four trial sites.
Who may be able to join
- Age > 18 years
- Willing to give informed consent
- Scheduled to receive neo-adjuvant or adjuvant paclitaxel treatment
- Able to speak and understand Danish
- Diagnosed with breast cancer
- Paclitaxel naïve patients
Who cannot join
- Neurodegenerative diseases (e.g., neuropathy from another cause, previous apoplexy, disc herniation
- Type 1 or 2 diabetes
- Pregnant
- Breastfeeding
- Relapse of cancer diagnosis
- Diagnosed with human immunodeficiency virus (HIV)
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- Participation in other clinical trials where the dose of paclitaxel is changed, or the aim is to prevent neuropathic pain or decrease NFL level (except if the intervention is to use cooling gloves).
- Previous treatment with neurotoxic chemotherapy
- Chronic pain from another cause
- Metastatic cancer
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Marianne Vogsen, +4550932282, marianne.vogsen@rsyd.dk
- Recruiting
University Hospital of Southern Denmark, Sønderborg
Sønderborg, 6400
Marianne Christensen, +4579973034, marianne.christensen.onk@rsyd.dk
- Recruiting
University Hospital of Southern Denmark, Vejle
Vejle, 7100
Lise Ventzel, +4579406060, lise.ventzel@rsyd.dk
About this study
Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.
Read the detailed description
The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles.
Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4.
The primary endpoint of the study is if serum NFL>100 pg/ml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Breastcancer patients | A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across three trial sites. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
NFL level correlation
The primary endpoint of the study is if serum NFL>100 pg/ml after first cycle (one cycle equals 3 weeks) of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.
Measured: Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary outcomes (9)
Paclitaxel exposure
To measure if high concentration of paclitaxel exposure is correlated to high NFL level in blood
Measured: Before treatment start and during four cycles (one cycle equals 3 weeks)
Genes and PIPN
To measure if genetic variants in genes (e.g., CYP2C8*3, EPHA4/5, FGD4) are associated with more server PIPN symptoms.
Measured: Before treatment start and during four cycles (one cycle equals 3 weeks)
Genes and NFL
To measure if genetic variants in genes (e.g., CYP2C8*3, EPHA4/5, FGD4) are associated with high NFL concentration in blood.
Measured: Before treatment start and during four cycles (one cycle equals 3 weeks)
Genes and Paclitaxel
To measure if genetic variants in genes (e.g., CYP2C8*3, EPHA4/5, FGD4) are associated with high paclitaxel concentration in blood.
Measured: Before treatment start and during four cycles (one cycle equals 3 weeks)
Drug-drug interactions
Investigate if and which specific drug-drug interactions are correlated to developing PIPN.
Measured: Before treatment start and during four cycles (one cycle equals 3 weeks)
Skin biopsies
Obtain skin biopsies from patients to elucidate which molecular mechanisms and phenotypes are associated with PIPN.
Measured: Before treatment start and during four cycles (one cycle equals 3 weeks)
IENFD
Obtain skin biopsies at baseline and at the beginning of cycle 3 or 4 (one cycle equals 3 weeks) to assess if the intraepidermal nerve fiber density (IENFD) changes during paclitaxel treatment.
Measured: Before treatment start and during four cycles (one cycle equals 3 weeks)
PHS
To assess whether the patients who have a sensation of heat during cooling of the skin (PHS) are also those who experience neuropathic pain.
Measured: Before treatment start and during four cycles (one cycle equals 3 weeks)
Nerve fiber dysfunction
To examine if increased NFL level is correlated to changes in small and large nerve fibers dysfunction.
Measured: Before treatment start and during four cycles (one cycle equals 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start10 Oct 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Sygehus Lillebaelt, Sonderborg Hospital
- Responsible party
- Sponsor
- Investigators
- Ditte Bork Iversen, Study chair, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430814
- Sponsor's protocol ID
- AKF-403
- Status last verified
- Aug 2025
- First submitted
- 25 Apr 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data on individual participants is not allowed due to GDPR
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06430814
- Acronym / sponsor ID
- AKF-403
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Sygehus Lillebaelt, Sonderborg Hospital
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 May 2024 (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.
Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.
Detailed description
The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles.
Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4.
The primary endpoint of the study is if serum NFL>100 pg/ml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breastcancer patients | – | Other: No interventionA total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across three trial sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across four trial sites.
Key inclusion criteria (6 listed)
- Age > 18 years
- Willing to give informed consent
- Scheduled to receive neo-adjuvant or adjuvant paclitaxel treatment
- Able to speak and understand Danish
- Diagnosed with breast cancer
Key exclusion criteria (10 listed)
- Neurodegenerative diseases (e.g., neuropathy from another cause, previous apoplexy, disc herniation
- Type 1 or 2 diabetes
- Pregnant
- Breastfeeding
- Relapse of cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Breastcancer patients |
Primary outcome
NFL level correlation
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
The primary endpoint of the study is if serum NFL>100 pg/ml after first cycle (one cycle equals 3 weeks) of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.
9 secondary outcomes
Paclitaxel exposure
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Genes and PIPN
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Genes and NFL
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Genes and Paclitaxel
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Drug-drug interactions
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Skin biopsies
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
IENFD
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
PHS
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Nerve fiber dysfunction
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No. Data on individual participants is not allowed due to GDPR
Related trials for Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
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.
Ditte Bork Iversen study chair
University of Southern Denmark
3 sites 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 University of Southern Denmark at 3 sites 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ditte Bork Iversen, MSc Pharm, PhD (+45 65 50 23 52, dbiversen@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NFL level correlation (time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)). 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 2 Sep 2025.