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

Namik Kemal University

Status

Enrolling

Conditions

Neuropathy Associated With Dysproteinaemias

Treatments

Drug: no intervention

Study type

Observational

Funder types

Other

Identifiers

NCT05622617

NEUROTOX

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria