Clinical trial NCT05011721: Digital Phenotyping in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
Official title: Digital Phenotyping (Physical Activity, Heart Rate, Sleep) in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: neoadjuvant
digital
prevention
activity tracker
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: NeoFit is a prospective, national, multicenter, single-arm open-label study. It will include a total of 300 participants under the age of 70 years treated with neoadjuvant chemotherapy for BC. Participants will receive a Withing Steel HR activity tracker, which they will be asked to wear 24 h per day for 12 months. The principal assessments will be performed at baseline, at the end of neoadjuvant chemotherapy and at 12 months. The investigators will evaluate clinical (e.g. toxicity, efficacy of chemotherapy), lifestyle, quality of life, fatigue, and physical activity parameters. All questionnaires will be completed on a REDCap form, via a secure internet link.

Detailed description: BACKGROUND: In young women, breast cancer (BC) has particular characteristics, such as a more advanced stage at diagnosis, aggressive tumor characteristics, and a poorer prognosis. NeoFit aims to use an activity tracker to identify and describe various digital profiles (physical activity, heart rate, sleep) in women under 70 years of age treated with neoadjuvant chemotherapy for BC.

METHODS: NeoFit is a prospective, national, multicenter, single-arm open-label study. It will include a total of 300 participants under the age of 70 years treated with neoadjuvant chemotherapy for BC. Participants will receive a Withing Steel HR activity tracker, which they will be asked to wear 24 h per day for 12 months. The principal assessments will be performed at baseline, at the end of neoadjuvant chemotherapy and at 12 months. The investigators will evaluate clinical (e.g. toxicity, efficacy of chemotherapy), lifestyle, quality of life, fatigue, and physical activity parameters. All questionnaires will be completed on a REDCap form, via a secure internet link.

DISCUSSION: NeoFit will make it possible, through the use of an activity tracker, to visualize changes, over a one-year period, in the lifestyle of young women treated for BC by neoadjuvant chemotherapy. This exploratory study will provide fundamental knowledge about the digital phenotypes of young BC patients treated with NAC and their relationships to chemotherapy toxicity and efficacy. This trial will pave the way for interventional studies on physical activity and sleep interventions.

Eligibility criteria: Inclusion criteria :

* female
* ≥ 18 years old and \<70 years old
* histologically confirmed BC, whatever the histological subtype (hormone receptor positive (RH+), negative (RH-), with (HER2+) overexpression or without (HER2-) HER2 overexpression, or triple negative)
* planned NAC (up to the day of the first neoadjuvant chemotherapy treatment)
* Eastern Cooperative Oncology Group Performance status ≤2
* willing to participate for the entire duration of the study
* ability to use a compatible smartphone or Tablet PC to download the application Withings Health Mate (from iOS 10 and Android 5.0 or above)
* Internet access
* valid health insurance
* able to read, write and understand French

Exclusion criteria :

* presence of metastases
* Presence of bilateral breast cancer
* a history of cancer other than basal cell skin lesions and cervical dysplasia
* pregnancy, likelihood of pregnancy, or breastfeeding
* impossibility of follow-up throughout the study for medical, social, family, geographic or psychological reasons
* deprived of liberty through a judicial or administrative decision.

Primary outcomes:
measure: Describe physical activity profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy
timeFrame: Month 12
measure: Describe heart rate profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy
timeFrame: Month 12
measure: Describe sleep profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy
timeFrame: Month 12
measure: Identify digital profiles (physical activity, heart rate, sleep) in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy
timeFrame: Month 12
Secondary outcomes:
measure: Analyze the effects of digital profiles on treatment toxicity
timeFrame: End of neoadjuvant chemotherapy, Month 12
measure: Analyze the effects of digital profiles on quality of life
timeFrame: End of neoadjuvant chemotherapy, Month 12
measure: Analyze the effects of digital profiles on fatigue
timeFrame: End of neoadjuvant chemotherapy, Month 12
measure: Develop models for predicting toxicity during the course of treatment
timeFrame: End of the neoadjuvant chemotherapy, Month 12
measure: Develop models for predicting fatigue changes during the course of treatment
timeFrame: End of the neoadjuvant chemotherapy, Month 12
measure: Develop models for predicting quality of life changes during the course of treatment
timeFrame: End of the neoadjuvant chemotherapy, Month 12
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint-Cloud
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Fabien Reyal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delrieu L, Hamy AS, Coussy F, Kassara A, Asselain B, Antero J, De Villele P, Dumas E, Forstmann N, Guerin J, Hotton J, Jouannaud C, Milder M, Leopold A, Sedeaud A, Soibinet P, Toussaint JF, Vercamer V, Laas E, Reyal F. Digital phenotyping in young breast cancer patients treated with neoadjuvant chemotherapy (the NeoFit Trial): protocol for a national, multicenter single-arm trial. BMC Cancer. 2022 May 4;22(1):493. doi: 10.1186/s12885-022-09608-y.