A proof-of-concept formative trial evaluating the interest of multiple connected devices for the early detection of hand-foot skin reactions in patients treated with regorafenib therapy (FACET).

Abstract

TPS207 Background: Hand-foot skin reaction (HFSR) is a common skin toxicity associated with regorafenib that may lead to drug withdrawal, dose reduction, or drug interruption. Predicting or recognizing early symptoms of HFSR could allow for better care. Digital solutions for ambulatory monitoring of patients provide an opportunity for monitoring and early detection of HFSR in home conditions. Methods: FACET is a phase 4, prospective, open-label, multicenter, interventional trial designed to assess the clinical utility, technical feasibility and usability of a system including a camera, FeetMe Connected insoles for gait assessment, ePRO questionnaires (HFS-14, EQ-5D-5L, FAS and VAS), and educational materials to detect and grade the severity of HFSR. During the study, enrolled patients developing an HFSR will be assigned to the HFSR group and patients without any sign of HFSR, they will be assigned to non-HFSR group. Study registration number at ANSM (French Authority): ID-RCB 2020-A03080-39. Patients will have metastatic colorectal cancer requiring initiation of regorafenib in accordance with clinical practice standard. Other key inclusion criteria are ECOG Performance Status 0-2, ability to understand the instructions and complete the ePRO questionnaires, ability to understand and communicate in French language, familiarity in using mobile communication devices and mobile application software, no previous episode of HFSR or HFS. The primary objective is to explore fit-for-purpose, and usability of the ePRO instruments and the data collecting devices. The primary endpoint is participants’ compliance with data collection measured by ePRO questionnaires completion, use of camera to take images vs expected and number of device days of insoles usage vs expected. Secondary objectives are to characterize variables exhibiting significant associations with development of HFSR. Secondary endpoints include summary statistics of ePRO questionnaires scores at the HFSR worst grade event in the HFSR group vs at 3 weeks in the non-HFSR group; Summary statistics for Feetme Connected insoles variables; Regorafenib dose modifications and treatment discontinuation; Participant’s device daily use to generate data; Participants ability to reach a hotline for technical issues or usability complaints. For HFSR related secondary endpoints, a blinded and independent Preliminary Adjudication Committee (PAC) will retrospectively assign participants to two groups (HFSR vs. no-HFSR) based on a case-by-case blinded assessment. An independent Final Adjudication Committee will compare the PAC assessment and investigators’ assessments done on site. It is planned to include a total of 38 participants from 4 centers. As of September 2021, all sites are open and ready to enroll. Study funded by Bayer.