Clinical trial · Interventional
Digital Phenotyping in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
Digital Phenotyping (Physical Activity, Heart Rate, Sleep) in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activity tracker | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention with activity tracker
- description
- Women allocated to the intervention arm will used an activity tracker
- interventionNames
- Device: Activity tracker
Primary outcomes (4)
- measure
- Describe physical activity profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy
- timeFrame
- Month 12
- description
- The activity tracker will register step counts for each day. the investigators will plot the average daily step counts and the 95% confidence interval across the entire study period. Then will will study the change in step count trajectory during the study. Linear mixed model will be used for describing change over time
- measure
- Describe heart rate profiles in breast cancer patients under 70 years of age treated by neoadjuvant chemotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDDelrieu 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. PMID 35509030