Risk Prediction of Taxane Chemotherapy-Induced Peripheral Neuropathy (SENSE)

Systemic Assessment of CIPN Risk Using Molecular Aging Trajectories

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Aging; Chemotherapy-induced Peripheral Neuropathy

Detailed Description

Chemotherapy-induced peripheral neuropathy is common and provokes pain, poor QoL, and loss of independence, as well as increases the risk of falls and opioid addiction. Beyond the inciting agents, risk factors for CIPN are not understood or systematically evaluated in clinical practice, precluding prevention. Therefore, a clinical decision tool to predict an individual patient's risk of neuropathy remains a critical unmet need. A diagnostic test that predicts CIPN risk in this clinical context would provide an essential clinical-decision tool to guide treatment and post-treatment care in breast cancer, prevent CIPN occurrence, and improve patient outcomes.

Investigators' pilot data uncovered a strong association between cellular senescence and CIPN. In this prospective, observational study of participants with early-stage breast cancer, the investigators will assess the contribution of senescence and clinical variables. The investigators will determine the ability of these factors to identify patients at risk for CIPN during chemotherapy and up to one year after the last dose of taxane-based chemotherapy. This study will employ both patient- and clinician reported CIPN scoring systems.

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals Adult Oncology Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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

Description

Inclusion Criteria:

Study participants must meet all of the following inclusion criteria to participate in the study:

• 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

Exclusion Criteria:

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change between baseline and the peak EORTC QLQ CIPN20 score during chemotherapy (continuous)	EORTC QLQ CIPN20	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grade 2 or higher CTCAE-CIPN during chemotherapy (binary)	CTCAE-CIPN	12 weeks
Dose reduction or discontinuation of chemotherapy (<85% of planned total dose delivered) (binary)	dose reduction or discontinuation	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)	dose reduction or discontinuation	12 weeks
Change between baseline and the EORTC QLQ-CIPN20 score at one year after the last taxane-based chemotherapy dose (continuous)	EORTC QLQ-CIPN20	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)	EORTC QLQ-CIPN20	1 year
Presence of grade 2 or higher CTCAE-CIPN at one year after the last taxane-based chemotherapy dose (binary)	CTCAE-CIPN	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculation of total chemotherapy dose delivered using a longitudinal cumulative dose of chemotherapy formula	Longitudinal cumulative dose of chemotherapy formula	12 weeks

Collaborators and Investigators

• Sponsor: Sapere Bio
• Collaborators: University of Alabama at Birmingham; National Institute on Aging (NIA); University of North Carolina
• Investigators: Principal Investigator: Natalia Mitin, PhD, Sapere Bio

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: June 12, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: SB-2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No