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Clinical Trials/NCT04068090
NCT04068090
Unknown
Not Applicable

Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 site in 1 country500 target enrollmentAugust 23, 2019
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Enrollment
500
Locations
1
Primary Endpoint
Total score from the FACT-GOG-Ntx questionnaire
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to collect clinical data, blood samples, and self reported symptoms of peripheral neuropathy from Chinese patients with breast cancer after treatment with taxanes. This data will be used to develop predictive markers for neuropathy.

Registry
clinicaltrials.gov
Start Date
August 23, 2019
End Date
December 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ma Fei,MD

Deputy Director

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of breast cancer
  • Females aged 16 and older
  • Planning to receive or previous treated with taxanes

Exclusion Criteria

  • Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity

Outcomes

Primary Outcomes

Total score from the FACT-GOG-Ntx questionnaire

Time Frame: Up to 2 years

Total score from the FACT-GOG-Ntx questionnaire for peripheral neuropathy, ranging from 0-44,higher value represents a worse outcome

Secondary Outcomes

  • Predictive value of genetic variants for the development of neuropathy(In the two weeks before start treatment)
  • Total score from the EORTC QLQ - CIPN20 questionnaire(Up to 2 years)

Study Sites (1)

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