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Completed

NCT Number: NCT05133947

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Bethune First Hospital Of Jilin University

Jilin City, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non Interventional

Other

Non interventional

Primary outcomes

  1. IENFD

    Time frame: 2021.10~2022.6

    IENFD change between CIPN patients and healthy subjects

Sponsors and collaborators

Lead sponsor

Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2021
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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