RecruitingNCT06430814

Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy


Sponsor

University of Southern Denmark

Enrollment

188 participants

Start Date

Oct 10, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria10

  • 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

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Interventions

OTHERNo intervention

No intervention


Locations(3)

Odense University Hospital

Odense, Denmark

University Hospital of Southern Denmark, Sønderborg

Sønderborg, Denmark

University Hospital of Southern Denmark, Vejle

Vejle, Denmark

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NCT06430814


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