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Trial Title:
Relationship Between Serum Interleukin-20 Level and Paclitaxel-associated Neuropathy
NCT ID:
NCT05622617
Condition:
Neuropathy Associated With Dysproteinaemias
Conditions: Official terms:
Peripheral Nervous System Diseases
Conditions: Keywords:
paclitaxel
peripheral neuropathy
Peripheral Neuropathy Induced by Paclitaxel
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
no intervention
Description:
no intervention
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.
Criteria for eligibility:
Study pop:
Patients receiving standard breast cancer treatment containing taxane
Sampling method:
Probability Sample
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
only the female gender will be enrolled
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tekirdag Namik Kemal University
Address:
City:
Tekirdağ
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Kubilay Karaboyun, m.d.
Phone:
+90 0 5542916110
Email:
kubilaykaraboyun@gmail.com
Start date:
January 1, 2022
Completion date:
April 1, 2023
Lead sponsor:
Agency:
Namik Kemal University
Agency class:
Other
Source:
Namik Kemal University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05622617
