Pre-study to Evaluate IENFD Induction in Patients With Taxane-induced CIPN

Completed

• Conditions: Peripheral Nervous System Diseases
• Interventions: Other: Non interventional

• Registration Number: NCT05133947
• Lead Sponsor: Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.

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.

Study Timeline

• Study Start: 2021-10-12
• Status Verified: 2021-11
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-24
• Primary Completion: 2022-03-01
• Study Completion: 2022-06-30
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CIPN patient	Non interventional	Patient with CIPN symptom
Healthy subject	Non interventional	Healthy subject

Primary Outcome Measures

Name	Time	Method
IENFD	2021.10~2022.6	IENFD change between CIPN patients and healthy subjects

Trial Locations

Locations (1)

Bethune First Hospital Of Jilin University; 🇨🇳 Jilin, China