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

Sponsor
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05133947
Collaborator
(none)
24
1
8.6
2.8

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
  • Other: Non interventional

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

Study Type:
Observational
Anticipated Enrollment :
24 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Clinical Study Examining Intraepidermal Nerve Fiber Density (IENFD) in Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN) Compared With Healthy Subjects
Actual Study Start Date :
Oct 12, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Jun 30, 2022

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

  1. IENFD [2021.10~2022.6]

    IENFD change between CIPN patients and healthy subjects

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05133947
Other Study ID Numbers:
  • BCRG-CN-001
First Posted:
Nov 24, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021