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

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ClinicalTrials.gov Identifier: NCT04932031
Recruitment Status : Not yet recruiting
First Posted : June 18, 2021
Last Update Posted : May 4, 2022
Sponsor:
Collaborators:
National Institute on Aging (NIA)
University of North Carolina
University of Alabama at Birmingham
Information provided by (Responsible Party):
Sapere Bio

Study Description
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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.

Condition or disease
Breast Cancer Chemotherapy-induced Peripheral Neuropathy Aging

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 Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systemic Assessment of CIPN Risk Using Molecular Aging Trajectories
Estimated Study Start Date : May 15, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change between baseline and the peak EORTC QLQ CIPN20 score during chemotherapy (continuous) [ Time Frame: 12 weeks ]
    EORTC QLQ CIPN20


Secondary Outcome Measures :
  1. Incidence of grade 2 or higher CTCAE-CIPN during chemotherapy (binary) [ Time Frame: 12 weeks ]
    CTCAE-CIPN

  2. Dose reduction or discontinuation of chemotherapy (<85% of planned total dose delivered) (binary) [ Time Frame: 12 weeks ]
    dose reduction or discontinuation

  3. 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) [ Time Frame: 12 weeks ]
    dose reduction or discontinuation

  4. Change between baseline and the EORTC QLQ-CIPN20 score at one year after the last taxane-based chemotherapy dose (continuous) [ Time Frame: 1 year ]
    EORTC QLQ-CIPN20

  5. 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) [ Time Frame: 1 year ]
    EORTC QLQ-CIPN20

  6. Presence of grade 2 or higher CTCAE-CIPN at one year after the last taxane-based chemotherapy dose (binary) [ Time Frame: 1 year ]
    CTCAE-CIPN


Other Outcome Measures:
  1. Calculation of total chemotherapy dose delivered using a longitudinal cumulative dose of chemotherapy formula [ Time Frame: 12 weeks ]
    Longitudinal cumulative dose of chemotherapy formula


Biospecimen Retention:   Samples With DNA
whole blood an plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   enrollment is based on the biological sex due to the nature of the disease
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
Criteria

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)
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Sapere Bio
ClinicalTrials.gov Identifier: NCT04932031    
Other Study ID Numbers: SB-2101
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases