Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068090
• Other study ID #: TIPN in China
• Status: Recruiting
• Start date: August 23, 2019
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Hongnan Mo, MD
• Phone: +86-10-87788200
• Email: mhnzlyynk[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Peripheral Nervous System Diseases

Intervention

Other:
• Patient Questionnaires
FACT-Ntx, EORTC-CIPN20
• Blood Collection
biomarker analysis

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score from the FACT-GOG-Ntx questionnaire	Total score from the FACT-GOG-Ntx questionnaire for peripheral neuropathy, ranging from 0-44,higher value represents a worse outcome	Up to 2 years
Secondary	Predictive value of genetic variants for the development of neuropathy	SNPs related to peripheral neuropathy	In the two weeks before start treatment
Secondary	Total score from the EORTC QLQ - CIPN20 questionnaire	Total score from the EORTC QLQ - CIPN20 questionnaire for peripheral neuropathy, ranging from 20-80,higher value represents a worse outcome	Up to 2 years