Pre-study to Evaluate IENFD Induction in Patients With Taxane-induced CIPN
Study Details
Study Description
Brief Summary
This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
CIPN patient Patient with CIPN symptom |
Other: Non interventional
Non interventional
|
Healthy subject Healthy subject |
Other: Non interventional
Non interventional
|
Outcome Measures
Primary Outcome Measures
- IENFD [2021.10~2022.6]
IENFD change between CIPN patients and healthy subjects
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Bethune First Hospital Of Jilin University | Jilin | China |
Sponsors and Collaborators
- Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
Investigators
- Study Chair: Frank Yan, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BCRG-CN-001