Digital phenotyping in young breast cancer patients treated with neoadjuvant chemotherapy (the NeoFit Trial): protocol for a national, multicenter single-arm trial
Lidia Delrieu,
Anne-Sophie Hamy,
Florence Coussy,
Amyn Kassara,
Bernard Asselain,
Juliana Antero,
Paul De Villèle,
Elise Dumas,
Nicolas Forstmann,
Julien Guérin,
Judicael Hotton,
Christelle Jouannaud,
Maud Milder,
Armand Leopold,
Adrien Sedeaud,
Pauline Soibinet,
Jean-François Toussaint,
Vincent Vercamer,
Enora Laas,
Fabien Reyal
Affiliations
Lidia Delrieu
Residual Tumor & Response To Treatment Laboratory, RT2Lab, Translational Research Department, INSERM, U932 Immunity and Cancer, Institut Curie, University Paris
Anne-Sophie Hamy
Residual Tumor & Response To Treatment Laboratory, RT2Lab, Translational Research Department, INSERM, U932 Immunity and Cancer, Institut Curie, University Paris
Florence Coussy
Residual Tumor & Response To Treatment Laboratory, RT2Lab, Translational Research Department, INSERM, U932 Immunity and Cancer, Institut Curie, University Paris
Amyn Kassara
Residual Tumor & Response To Treatment Laboratory, RT2Lab, Translational Research Department, INSERM, U932 Immunity and Cancer, Institut Curie, University Paris
Bernard Asselain
GINECO Group
Juliana Antero
Institute for Biomedical and Epidemiological Research in Sport, France University
Paul De Villèle
Elise Dumas
Residual Tumor & Response To Treatment Laboratory, RT2Lab, Translational Research Department, INSERM, U932 Immunity and Cancer, Institut Curie, University Paris
Nicolas Forstmann
Institute for Biomedical and Epidemiological Research in Sport, France University
Julien Guérin
Data Office, Institut Curie
Judicael Hotton
Department of Surgical Oncology, Institut de Cancérologie Jean-Godinot
Christelle Jouannaud
Department of Medical Oncology, Institut de Cancérologie Jean-Godinot
Maud Milder
Data Office, Institut Curie
Armand Leopold
Data Office, Institut Curie
Adrien Sedeaud
Institute for Biomedical and Epidemiological Research in Sport, France University
Pauline Soibinet
Department of Medical Oncology, Institut de Cancérologie Jean-Godinot
Jean-François Toussaint
Institute for Biomedical and Epidemiological Research in Sport, France University
Vincent Vercamer
Enora Laas
Residual Tumor & Response To Treatment Laboratory, RT2Lab, Translational Research Department, INSERM, U932 Immunity and Cancer, Institut Curie, University Paris
Fabien Reyal
Residual Tumor & Response To Treatment Laboratory, RT2Lab, Translational Research Department, INSERM, U932 Immunity and Cancer, Institut Curie, University Paris
Abstract Background Breast cancer (BC) has particular characteristics in young women, with diagnosis at more advanced stages, a poorer prognosis and highly aggressive tumors. In NeoFit, we will use an activity tracker to identify and describe various digital profiles (heart rate, physical activity, and sleep patterns) in women below the age of 45 years on neoadjuvant chemotherapy for BC. Methods NeoFit is a prospective, national, multicenter, single-arm open-label study. It will include 300 women below the age of 45 years treated with neoadjuvant chemotherapy for BC. Participants will be asked to wear a Withing Steel HR activity tracker round the clock for 12 months. The principal assessments will be performed at baseline, at the end of neoadjuvant chemotherapy and at 12 months. We will evaluate clinical parameters, such as toxicity and the efficacy of chemotherapy, together with quality of life, fatigue, and parameters relating to lifestyle and physical activity. The women will complete REDCap form questionnaires via a secure internet link. Discussion In this study, the use of an activity tracker will enable us to visualize changes in the lifestyle of young women on neoadjuvant chemotherapy for BC, over the course of a one-year period. This exploratory study will provide crucial insight into the digital phenotypes of young BC patients on neoadjuvant chemotherapy and the relationship between these phenotypes and the toxicity and efficacy of treatment. This trial will pave the way for interventional studies involving sleep and physical activity interventions. Trial registration Clinicaltrials.gov identifier: NCT05011721 . Registration date: 18/08/2021.
