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

NCT ID: NCT05622617

Last Updated: 2022-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-04-01

Brief Summary

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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

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* 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.

Conditions

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Neuropathy Associated With Dysproteinaemias

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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no intervention

no intervention

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Namik Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Asoc. Prof. Erdoğan Selçuk Şeber

Asoc Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tekirdag Namik Kemal University

Tekirdağ, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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kubilay karaboyun, m.d.

Role: CONTACT

+90 0554 2916110

Facility Contacts

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Kubilay Karaboyun, m.d.

Role: primary

+90 0 5542916110

Other Identifiers

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NEUROTOX

Identifier Type: -

Identifier Source: org_study_id

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