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

Sponsor
Namik Kemal University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05622617
Collaborator
(none)
50
Enrollment
1
Location
14.9
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prospective Observational Investigation of Serum Interleukin-20 Level and Paclitaxel-Associated Neuropathy in Breast Cancer Patients Receiving Paclitaxel Chemotherapy
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Relationship with paclitaxel associated neuropathy and serum IL-20 level [January 01,2022 -December 31, 2022 is the deadline for patient inclusion]

    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

  2. Relationship with paclitaxel associated neuropathy and serum IL-20 level [December 31, 2022 is the deadline for patient inclusion]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tekirdag Namik Kemal University Tekirdağ Turkey

Sponsors and Collaborators

  • Namik Kemal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asoc. Prof. Erdoğan Selçuk Şeber, Asoc Prof., Namik Kemal University
ClinicalTrials.gov Identifier:
NCT05622617
Other Study ID Numbers:
  • NEUROTOX
First Posted:
Nov 18, 2022
Last Update Posted:
Nov 18, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Asoc. Prof. Erdoğan Selçuk Şeber, Asoc Prof., Namik Kemal University
paclitaxel
peripheral neuropathy
Peripheral Neuropathy Induced by Paclitaxel
Additional relevant MeSH terms:
Peripheral Nervous System Diseases

Study Results

No Results Posted as of Nov 18, 2022