Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy

NCT06430814 | Recruiting

• 1 other identifier: AKF-403
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 3

Brief Summary

Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Before treatment start and during four cycles (one cycle equals 3 weeks)

Secondary Outcomes (9)

• Paclitaxel exposure

  Before treatment start and during four cycles (one cycle equals 3 weeks)

• Genes and PIPN

  Before treatment start and during four cycles (one cycle equals 3 weeks)

• Genes and NFL

  Before treatment start and during four cycles (one cycle equals 3 weeks)

• Genes and Paclitaxel

  Before treatment start and during four cycles (one cycle equals 3 weeks)

• Drug-drug interactions

  Before treatment start and during four cycles (one cycle equals 3 weeks)

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Breastcancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator
• Sygehus Lillebaelt: collaborator
• Sonderborg Hospital: collaborator

Study Sites (3)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

University Hospital of Southern Denmark, Sønderborg

Sønderborg, 6400, Denmark

RECRUITING

University Hospital of Southern Denmark, Vejle

Vejle, 7100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The investigators are taking blood samples to analyze the NFL level, paclitaxel concentration, and looking at DNA sequencing associated with PIPN. The investigators will also take skin biopsies to look at the nerve fiber density and if gene and protein expression of relevant genes changes following paclitaxel treatment.

Study Officials

• Ditte Bork Iversen

  University of Southern Denmark

  STUDY CHAIR

Central Study Contacts

Ditte Bork Iversen, MSc Pharm, PhD

CONTACT

+45 65 50 23 52; dbiversen@health.sdu.dk

Tore B. Stage, Prof

CONTACT

+45 65 50 36 78; tstage@health.sdu.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 28, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)