Clinical Research Directory
Browse clinical research sites, groups, and studies.
Fasten Onco Digital Therapy During Neoadjuvant Treatment for Triple-Negative Breast Cancer
Sponsor: FASTEN
Summary
This randomized, multicenter, open-label clinical study will evaluate whether adding the Fasten Onco digital therapy, which supports a fasting-mimicking diet (FMD), to standard neoadjuvant treatment can reduce treatment-related fatigue in adult women with stage II or III triple-negative breast cancer. Participants will be randomly assigned to receive either standard neoadjuvant treatment alone or standard neoadjuvant treatment together with the Fasten Onco program. Participants assigned to Fasten Onco will follow a short fasting-mimicking diet around treatment cycles, supported by the Fasten Onco digital application and under medical supervision. The main objective is to compare fatigue between the two groups during neoadjuvant treatment. The study will also assess quality of life, treatment-related side effects, pathological response to treatment, and participants' adherence to and satisfaction with the Fasten Onco program.
Official title: A Randomized, Multicentric, Open-Label Trial to Investigate the Benefit of Adding Fasten Onco Digital Therapy Integrating a Fasting Mimicking Diet During Neoadjuvant Treatment to Standard of Care, Compared to Standard of Care Alone, in Women (Aged 18 Years or Older), With Early-Stage II/III Triple-Negative Breast Cancer (FAST-01)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2026-10-30
Completion Date
2029-06-30
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Fasten Onco
Fasten Onco is a digital medical device designed to support the implementation of a fasting-mimicking diet (FMD) during neoadjuvant treatment. The device provides a personalized nutritional program synchronized with the participant's treatment schedule, together with educational content, reminders, and guidance to support adherence. The program is prescribed and configured by a healthcare professional and is used under medical supervision.
Standard Neoadjuvant Treatment
Standard neoadjuvant treatment for stage II/III triple-negative breast cancer according to the standard of care at each participating center. Treatment may include paclitaxel, carboplatin, epirubicin or doxorubicin, cyclophosphamide, and pembrolizumab, used within their approved indications. Standard neoadjuvant treatment is administered in both study groups.
Locations (7)
Hôpital Privé de Provence
Aix-en-Provence, France
Centre Hospitalier de Bligny
Briis-sous-Forges, France
Hôpital Privé Jean Mermoz
Lyon, France
Institut Paoli-Calmettes
Marseille, France
CHU de Montpellier
Montpellier, France
Hôpital Américain de Paris
Neuilly-sur-Seine, France
Clinique Saint Jean de Dieu
Paris, France