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NCT Number: NCT06430814

Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy

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

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Odense University Hospital, Odense, Denmark

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Paclitaxel exposure

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

    To measure if high concentration of paclitaxel exposure is correlated to high NFL level in blood

  2. Genes and PIPN

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

    To measure if genetic variants in genes (e.g., CYP2C8*3, EPHA4/5, FGD4) are associated with more server PIPN symptoms.

  3. Genes and NFL

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

    To measure if genetic variants in genes (e.g., CYP2C8*3, EPHA4/5, FGD4) are associated with high NFL concentration in blood.

  4. Genes and Paclitaxel

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

    To measure if genetic variants in genes (e.g., CYP2C8*3, EPHA4/5, FGD4) are associated with high paclitaxel concentration in blood.

  5. Drug-drug interactions

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

    Investigate if and which specific drug-drug interactions are correlated to developing PIPN.

  6. Skin biopsies

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

    Obtain skin biopsies from patients to elucidate which molecular mechanisms and phenotypes are associated with PIPN.

  7. IENFD

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

    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.

  8. PHS

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

    To assess whether the patients who have a sensation of heat during cooling of the skin (PHS) are also those who experience neuropathic pain.

  9. Nerve fiber dysfunction

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

    To examine if increased NFL level is correlated to changes in small and large nerve fibers dysfunction.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital
  • Sonderborg Hospital
  • Sygehus Lillebaelt

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 28, 2024
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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