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Status unknownNCT05622617NEUROTOXUpdated Nov 18, 2022

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

An observational study in Neuropathy Associated With Dysproteinaemias, sponsored by Namik Kemal University. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by Namik Kemal University · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
Female
01

Study 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

Read the 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.
02

Conditions studied

  • Neuropathy Associated With Dysproteinaemias

Keywords

  • paclitaxel
  • peripheral neuropathy
  • Peripheral Neuropathy Induced by Paclitaxel
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's planned enrollment of 50 is below the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Namik Kemal University is the lead sponsor of 57 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients receiving standard breast cancer treatment containing taxane

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • advanced stage breast cancer
  • having before peripheral neuropathy
  • patients with diabetes mellitus
  • \< 18 years
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Drugno intervention

    no intervention

06

What researchers measure

Primary outcomes

  1. Relationship with paclitaxel associated neuropathy and serum IL-20 level

    Neuropathy 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

    Time frame: January 01,2022 -December 31, 2022 is the deadline for patient inclusion

  2. Relationship with paclitaxel associated neuropathy and serum IL-20 level

    Neuropathy 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

    Time frame: December 31, 2022 is the deadline for patient inclusion

07

Study locations

1 of 1 sites recruiting
  • Tekirdag Namik Kemal University
    Tekirdağ, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05622617
Lead sponsor
Namik Kemal University
Responsible party
Asoc. Prof. Erdoğan Selçuk Şeber (Asoc Prof., Namik Kemal University) — Principal investigator
First posted
Nov 18, 2022
Start date
Jan 1, 2022
Primary completion
Mar 1, 2023 (estimated)
Completion
Apr 1, 2023 (estimated)
Last update
Nov 18, 2022

Study contacts

kubilay karaboyun, m.d.
Contact
kubilaykaraboyun@gmail.com
+90 0554 2916110

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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