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

Peripheral Nervous System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05133947
• Other study ID #: BCRG-CN-001
• Status: Completed
• Start date: October 12, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2021
• Source: Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nervous System Diseases
• Peripheral Nervous System Diseases

Intervention

Other:
• Non interventional
Non interventional

Locations

Country	Name	City	State
China	Bethune First Hospital Of Jilin University	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IENFD	IENFD change between CIPN patients and healthy subjects	2021.10~2022.6