Chemotherapy induced peripheral neuropathy (CIPN) is a major side effect of oxaliplatin, a key drug in 1stline regimens for treating colorectal cancer. Dose-limiting CIPN prevents >25% of patients from receiving full,maximally effective dose of oxaliplatin. In addition, 10-40% of patients receiving oxaliplatin-based therapy forcolorectal cancer with develop chronic CIPN, which is painful, impairs quality of life, and is associated withhigher opioid use rates. Approaches for CIPN prevention have not yielded meaningful success.A biomarker that can help with early prediction of CIPN will be a major facilitator of shared decision making(i.e. changing chemotherapy intensity, frequency, or type) to prevent CIPN, and in stratifying patients totargeted clinical trials for CIPN prevention. To that end, we have recently characterized the Allo-ColdTM methodfor early prediction of CIPN, based on dynamic quantification of cold hypersensitivity. In preliminary studies,the method demonstrated promising sensitivity and specificity. It is non-invasive, scalable, and has a potentialto be readily implementable, including in low-resource settings.Our main goal for this Phase I STTR proposal is to develop and test a user-centered mobile health systemprototype for collecting, storing, aggregating and processing patient-reported data on palmar cold sensitivity topredict CIPN.In Aim 1, we will develop the Allo-Cold mobile health technology prototype using a user-centered designapproach. We will use three-tier architecture to develop the patient user interface, data management andstorage, and data logic components of a mobile app for CIPN risk prediction. We will iteratively test and refinethe prototype. We will conduct interviews with cancer patients for feedback on prototype acceptability, and withclinicians to assess implementation barriers.In Aim 2, we will demonstrate adherence and predictive performance of Allo-Cold system in patientsundergoing oxaliplatin-based chemotherapy. Twenty-four patients with stage III/IV colorectal cancerundergoing oxaliplatin-based therapy will use Allo-Cold, and self-report cold pain and cold unpleasantnessdaily for 10 weeks (5 cycles) of chemotherapy. We will determine patient adherence and the performance ofour predictive algorithm in predicting dose-limiting CIPN.In this Phase I STTR proposal, we expect to determine the feasibility of the Allo-Cold system by confirmingits usability, adherence, and predictive performance in the context of oxaliplatin-based therapy for colorectalcancer. Phase II STTR proposal will focus on completing full clinical and analytical validation of Allo-Cold as apredictive biomarker for CIPN, toward FDA approval and subsequent commercialization.
Public Health Relevance Statement: PROJECT NARRATIVE (PUBLIC HEALTH RELEVANCE)
Chemotherapy-induced peripheral neuropathy (CPIN) is a major painful and dose-limiting complication of
oxaliplatin, a life-saving drug for colorectal cancer. In the proposed studies, we will test a novel non-invasive
technology, Allo-Cold, for early prediction of CIPN, and determine its feasibility and performance characteristics.
This technology, be predicting CIPN risk, can help shared decision making to avoid or prevent CIPN, and thus
minimize pain, quality of life impairment, and need for opioid medications in patients with colorectal cancer.
Project Terms: <1-OHP> 