A Clinical Study Examining Intraepidermal Nerve Fiber Density (IENFD) in Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN) Compared With Healthy Subjects

Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.1 site in 1 country24 target enrollmentOctober 12, 2021

ConditionsPeripheral Nervous System Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Nervous System Diseases
Sponsor: Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
Enrollment: 24
Locations: 1
Primary Endpoint: IENFD
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects.

Detailed Description

This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects. After the subjects sign the informed consent, the study physicians will judge the inclusion and exclusion criteria. Subjects meeting the inclusion requirements will register at the study center according to the requirements of the study physicians, and skin samples will be collected by specialized researchers.

Registry

clinicaltrials.gov

Start Date

October 12, 2021

End Date

June 30, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Received taxane adjuvant chemotherapy for breast cancer for curative purposes and completed chemotherapy before entering the study; Persistent peripheral neuropathy of the lower extremities;
•CIPN Severity:
•The presence of at least one of the following symptoms on both lower extremities in a gloved and sock glove pattern: pain or burning, numbness, or tingling.
•Examination of the lower extremities showed needling loss of both legs; Neurological symptoms occur after exposure to taxane and cannot be attributed to any other neurological disease; NRS rating ≥ 4.

Exclusion Criteria

•Pregnant or lactating women. Presence of any neuropathy other than CIPN. According to the investigator's judgment, there are skin diseases in the affected skin area that may interfere with the evaluation of neuropathic pain symptoms, or diseases at the skin biopsy site that may affect the epidermal nerve morphology, or other factors.
•The presence of non-CIPN pain may interfere with study evaluation and/or peripheral neuropathic pain self-assessment.