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

NCT ID: NCT05133947

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2022-06-30

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.

Conditions

Peripheral Nervous System Diseases

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

CIPN patient

Patient with CIPN symptom

Non interventional

Intervention Type: OTHER

Non interventional

Healthy subject

Healthy subject

Non interventional

Intervention Type: OTHER

Non interventional

Interventions

Non interventional

Non interventional

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaojiao Li

Role: PRINCIPAL_INVESTIGATOR

China

Locations

Bethune First Hospital Of Jilin University

Jilin, , China

Countries

China

Other Identifiers

BCRG-CN-001

Identifier Type: -

Identifier Source: org_study_id