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Relationship Between Serum Interleukin-20 Level and Paclitaxel-associated Neuropathy

Prospective Observational Investigation of Serum Interleukin-20 Level and Paclitaxel-Associated Neuropathy in Breast Cancer Patients Receiving Paclitaxel Chemotherapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05622617
Acronym
NEUROTOX
Enrollment
50
Registered
2022-11-18
Start date
2022-01-01
Completion date
2023-04-01
Last updated
2022-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathy Associated With Dysproteinaemias

Keywords

paclitaxel, peripheral neuropathy, Peripheral Neuropathy Induced by Paclitaxel

Brief summary

This study aims to investigate the correlation between paclitaxel-induced neuropathy and the measurement values of serum IL-20 levels at baseline and during chemotherapy in patients who will receive neoadjuvant or adjuvant paclitaxel chemotherapy with the diagnosis of early-stage or locally advanced breast cancer

Detailed description

* Patients with the diagnosis of breast cancer who will be started on adjuvant or neoadjuvant paclitaxel chemotherapy will be included in the study. * Patients who will receive standard breast cancer treatment (4 cycles of cyclophosphamide 600mg/m2 every 21 days + epirubicin 90mg/m2 followed by weekly paclitaxel 80 mg/m2 x 12 sessions) will be included in the study. * Age, gender, additional disease, diagnosis dates, previous diseases and breast cancer subtypes of the patients who signed the informed consent form will be obtained from the electronic information system or by asking face-to-face. * Serum IL-20 level will be studied from blood tests taken for routine chemotherapy. no extra blood sample will be taken for the study * Neuropathy assessment will be evaluated with Organisation for Research and Treatment of Cancer (EORTC) chemotherapy-induced peripheral neuropathy (QLQ-CIPN20) Questionnaire, the sensitivity, and specificity of which have previously been demonstrated for chemotherapy-induced neuropathy. The Turkish validation questionnaire of the study, which was made before, will be conducted by the physician in charge before the paclitaxel chemotherapy and at the 1st and 12th weeks after the treatment, by asking the patient face to face. * patients with diabetes mellitus and patients who had a history of peripheral neuropathy will be excluded from the study.

Interventions

DRUGno intervention

no intervention

Sponsors

Namik Kemal University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients receiving paclitaxel chemotherapy for local advanced or early-stage breast cancer * \>18 years

Exclusion criteria

* advanced stage breast cancer * having before peripheral neuropathy * patients with diabetes mellitus * \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
Relationship with paclitaxel associated neuropathy and serum IL-20 levelJanuary 01,2022 -December 31, 2022 is the deadline for patient inclusionNeuropathy measurement will be made face-to-face by the attending physician with a European Organisation for Research and Treatment of Cancer (EORTC) Chemotherapy-induced peripheral neuropathy (CIPN) Questionnaire after the first week after paclitaxel chemotherapy and the last week of 12 cycles of treatment

Countries

Turkey (Türkiye)

Contacts

Primary Contactkubilay karaboyun, m.d.
kubilaykaraboyun@gmail.com+90 0554 2916110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026