# Multi-Omic Biomarkers for Neuropathic Pain Secondary to Chemotherapy

> **NIH NIH R61** · CLEVELAND CLINIC LERNER COM-CWRU · 2020 · $4,775,386

## Abstract

PROJECT SUMMARY
Taxanes are among the most efficacious chemotherapeutic agents and are frequently used in the treatment of
early stage and metastatic breast cancer, but are known to produce a pain condition known as chemotherapy-
induced peripheral neuropathic pain (CIPNP). CIPNP is one of the primary dose-limiting toxicities of taxane
administration. No diagnostic tool exists to identify patients that will develop CIPNP in response to taxane
therapy. To address this unmet clinical need, this proposal seeks to develop biomarker signatures associated
with taxane-induced neuropathic pain to 1) identify patients at risk for developing debilitating taxane neuropathic
pain before chemotherapy is initiated and 2) to identify patients on treatment that are at risk of developing
neuropathic pain and need dose adjustments to prevent the onset of symptoms. Our long-term goal is to identify
biomarker signatures that can identify patients at high risk of developing taxane-induced CIPNP to enable
personalized dose adjustments to minimize CIPNP and optimize therapeutic outcomes. During the R61 phase,
we will perform genome-wide, epigenome-wide, miRNome-wide, and untargeted metabolome-wide associations
of the 11-point pain-intensity Numerical Rating Scale (NRS), Chemotherapy-induced peripheral neuropathy 20-
item (CIPN20), the Pain Catastrophizing Scale (PCS), and Patient Reported Outcome Measurement System
(PROMIS) scores for physical function, anxiety, depression, and pain interference to identify novel biomarkers
associated with identifiable phenotypes (Aim 1A). Next, we will test panels of candidate mRNA and cytokine
biomarkers for their association with NRS, CIPN20, PCS, and PROMIS scores (Aim 1B). An added strength of
this study is that by collecting samples before, during, and after taxane treatment we will be able to compare
those patients who develop CIPNP to those that remain pain free, providing a better understanding of the
molecular mechanism predisposing a patient to developing neuropathic pain. R61 milestones include developing
biomarker signatures that identify patients at risk of developing neuropathic pain that compromise quality of life
(i) before taxane therapy is started and (ii) over the time course of taxane therapy. One rationale is that some
patients will have a detectable biomarker profile suggesting a high likelihood of long term (i.e., greater than 1
year) neuropathic pain and a need to either avoid or reduce taxane doses. A second rationale is that some
patients may not have a biomarker signature indicating an adverse response to taxane therapy at baseline, but
develop one through the course of taxane therapy. This biomarker signature will be used to detect these
susceptible patients early and personalize their taxane therapy to minimize CIPNP. In the R33 phase (Aim 2),
we will use machine learning to develop and validate algorithms using biomarker signatures from associations
with phenotypic changes from Aim 1 (A and B) to predict ...

## Key facts

- **NIH application ID:** 10056337
- **Project number:** 1R61NS113258-01A1
- **Recipient organization:** CLEVELAND CLINIC LERNER COM-CWRU
- **Principal Investigator:** JOSEPH F FOSS
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $4,775,386
- **Award type:** 1
- **Project period:** 2020-09-30 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10056337

## Citation

> US National Institutes of Health, RePORTER application 10056337, Multi-Omic Biomarkers for Neuropathic Pain Secondary to Chemotherapy (1R61NS113258-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10056337. Licensed CC0.

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