This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects.
Full Title of Study: “A Clinical Study Examining Intraepidermal Nerve Fiber Density (IENFD) in Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN) Compared With Healthy Subjects”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 1, 2022
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.
- Other: Non interventional
- Non interventional
Arms, Groups and Cohorts
- CIPN patient
- Patient with CIPN symptom
- Healthy subject
- Healthy subject
Clinical Trial Outcome Measures
- Time Frame: 2021.10~2022.6
- IENFD change between CIPN patients and healthy subjects
Participating in This Clinical Trial
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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Frank Yan, Study Chair, China
- Overall Contact(s)
- Raylene Liu, +86 15862378343, email@example.com
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