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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05133947
Other study ID # BCRG-CN-001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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