Risk Prediction of Taxane Chemotherapy-Induced Peripheral Neuropathy

Breast Cancer Clinical Trial

— SENSE  

Official title:

Systemic Assessment of CIPN Risk Using Molecular Aging Trajectories

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04932031
• Other study ID #: SB-2101
• Status: Terminated
• Start date: May 25, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Sapere Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Breast Cancer
• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	UNC Hospitals Adult Oncology Clinics	Chapel Hill	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Sapere Bio	National Institute on Aging (NIA), University of Alabama at Birmingham, University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Calculation of total chemotherapy dose delivered using a longitudinal cumulative dose of chemotherapy formula	Longitudinal cumulative dose of chemotherapy formula	12 weeks
Primary	Change between baseline and the peak EORTC QLQ CIPN20 score during chemotherapy (continuous)	EORTC QLQ CIPN20	12 weeks
Secondary	Incidence of grade 2 or higher CTCAE-CIPN during chemotherapy (binary)	CTCAE-CIPN	12 weeks
Secondary	Dose reduction or discontinuation of chemotherapy (<85% of planned total dose delivered) (binary)	dose reduction or discontinuation	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Presence of grade 2 or higher CTCAE-CIPN at one year after the last taxane-based chemotherapy dose (binary)	CTCAE-CIPN	1 year