Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07884721
NA

Fasten Onco Digital Therapy During Neoadjuvant Treatment for Triple-Negative Breast Cancer

Sponsor: FASTEN

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DRUG

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