NCT04932031

Brief Summary

This is an observational study to discover risk factors of chemotherapy-induced peripheral neuropathy (CIPN) in 350 patients with early stage breast cancer undergoing taxane-based chemotherapy at two main sites (University of North Carolina at Chapel Hill (UNC) Hospital, including Rex Hospital, and the University of Alabama at Birmingham (UAB) Hospital). The primary purpose of this study to explore patient- and procedure-based variables that identify patients at risk for developing CIPN during chemotherapy.

Trial Health

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Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

June 12, 2021

Last Update Submit

November 1, 2023

Conditions

Breast CancerChemotherapy-induced Peripheral NeuropathyAging

Outcome Measures

Primary Outcomes (1)

  • Change between baseline and the peak EORTC QLQ CIPN20 score during chemotherapy (continuous)

    EORTC QLQ CIPN20

    12 weeks

Secondary Outcomes (6)

  • Incidence of grade 2 or higher CTCAE-CIPN during chemotherapy (binary)

    12 weeks

  • Dose reduction or discontinuation of chemotherapy (<85% of planned total dose delivered) (binary)

    12 weeks

  • Dose reduction or discontinuation of the taxane portion of the chemotherapy, if administered separately from the rest of the chemotherapy agents (<85% of planned total dose delivered) (binary)

    12 weeks

  • Change between baseline and the EORTC QLQ-CIPN20 score at one year after the last taxane-based chemotherapy dose (continuous)

    1 year

  • Presence of CIPN at one year after the last taxane based chemotherapy dose that is an EORTC QLQ-CIPN20 score of 3 points or higher than baseline (binary)

    1 year

  • +1 more secondary outcomes

Other Outcomes (1)

  • Calculation of total chemotherapy dose delivered using a longitudinal cumulative dose of chemotherapy formula

    12 weeks

Study Arms (1)

Study group

Adult females with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsenrollment is based on the biological sex due to the nature of the disease
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult female study participants (≥18 years) with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel

You may qualify if:

  • Adult female study participants (≥18 years) with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel
  • Study participants must be capable and willing to provide informed consent, and be willing and able to complete the study questionnaires during the study

You may not qualify if:

  • Study participants who fulfill any of the following criteria will be excluded:
  • Patients with metastatic breast cancer
  • History of other cancers (except squamous and basal cell carcinoma)
  • Autoimmune disorders
  • Presence of major active infection for which antibiotics and/or antivirals are prescribed within the last 14 days (chronic or acute, eg, sepsis, HIV, pneumonia, active COVID infection)
  • Pregnant women
  • Participation in an additional study at the time of enrollment where the intervention could potentially alter CIPN risk (unless in the control arm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

UNC Hospitals Adult Oncology Clinics

Chapel Hill, North Carolina, 27514, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood an plasma

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Natalia Mitin, PhD

    Sapere Bio

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 18, 2021

Study Start

May 25, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 3, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)