NCT05133947

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 3, 2023

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

November 4, 2021

Last Update Submit

March 30, 2023

Conditions

Peripheral Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

  • IENFD

    IENFD change between CIPN patients and healthy subjects

    2021.10~2022.6

Study Arms (2)

CIPN patient

Patient with CIPN symptom

Other: Non interventional

Healthy subject

Healthy subject

Other: Non interventional

Interventions

Non interventionalOTHER

Non interventional

CIPN patientHealthy subject

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18-70 years old CIPN Patients and healthy subjects.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bethune First Hospital Of Jilin University

Jilin, China

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Study Officials

  • Xiaojiao Li

    China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2021

First Posted

November 24, 2021

Study Start

October 12, 2021

Primary Completion

March 1, 2022

Study Completion

June 30, 2022

Last Updated

April 3, 2023

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)