Relationship Between Serum Interleukin-20 Level and Paclitaxel-associated Neuropathy (NEUROTOX)

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

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

Study Overview

• Status: Recruiting
• Conditions: Neuropathy Associated With Dysproteinaemias
• Intervention / Treatment: Drug: no intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: kubilay karaboyun, m.d.; Phone Number: +90 0554 2916110; Email: kubilaykaraboyun@gmail.com

Study Locations

• Turkey
  • Tekirdağ, Turkey
    • Recruiting
    • Tekirdag Namik Kemal University
    • Contact: Kubilay Karaboyun, m.d.; Phone Number: +90 0 5542916110; Email: kubilaykaraboyun@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients receiving standard breast cancer treatment containing taxane

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	January 01,2022 -December 31, 2022 is the deadline for patient inclusion
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	December 31, 2022 is the deadline for patient inclusion

Collaborators and Investigators

• Sponsor: Namik Kemal University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: October 2, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: paclitaxel; peripheral neuropathy; Peripheral Neuropathy Induced by Paclitaxel
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: NEUROTOX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No