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.
Investigators
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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