Fasten Onco Digital Therapy During Neoadjuvant Treatment for Triple-Negative Breast Cancer (FAST-01)

FASTEN

Status: Not yet enrolling

Conditions: Triple-Negative Breast Cancer (TNBC)

Treatments: Device: Fasten Onco; Drug: Standard Neoadjuvant Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT07884721

2025-A02737-42 (Other Identifier)

FASTEN-01

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• - Patient has provided written informed consent before participating in the trial.
• Women aged ≥18 years.
• Patient with documented diagnosis of stage II/III triple negative breast cancer (TNBC) as per ESMO guidelines.
• Patient with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Patient has adequate bone marrow function.
• Patient has adequate renal function.
• Patient has adequate liver function.
• Patient has adequate heart function, i.e., no signs of heart failure or clinically significant arrhythmia.
• Patient has completed the FACIT-Fatigue and FACT-G questionnaires at baseline.
• Patient has access to a smart phone with access to the internet.
• Patient with a weighing scale to measure weight.
• Patient is able and willing to complete the trial, including the assigned questionnaires.
• Patient can read and write in French.
• Patient is covered by the French social security insurance or a similar healthcare insurance.

Exclusion criteria

• Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (covering all protected persons: pregnant women, women in labour, breastfeeding mothers, persons deprived of their liberty by judicial or administrative order, minors, and persons subject to a legal protection measure: guardianship or curatorship).
• Patient with prior breast cancer (invasive or non-invasive breast cancer).
• Patient with a history of cancer within the last 5 years, except for basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
• Patient diagnosed with type I or II diabetes and treated.
• Patient with a body mass index (BMI) <18.5 kg/m² or patients with a BMI between 18.5 kg/m² and 20 kg/m² and weight loss ≥5% in the last 3 months or if a BMI >20 kg/m² and weight loss >10% in last 3 months.
• Patient with food allergies.
• Patient with metabolic disorders affecting gluconeogenesis or adaptation to short periods of fasting.
• Patient already treated with a chronic immunosuppressive drug (dexamethasone used according to SOC is permitted) >10 mg per day of prednisone or equivalent at study entry.
• Previous episodes of symptomatic hypotension leading to loss of consciousness.
• Previous episodes of symptomatic hypoglycemia.
• Patient with behavioral eating disorders.
• Patient already following a fasting or fasting mimicking diet.
• Use of herbal preparations or medications interfering with chemoimmunotherapy pharmacokinetics: St. John's wort, kava, ephedra (ma huang), gingko biloba, aloe vera (and its derivatives), artemisinin (and its derivatives), and dehydroepiandrosterone (DHEA).
• Use of vitamins or food supplements exceeding one-tenth (1/10) of the daily recommended dose except for vitamin D or containing calories.
• Use of any supplement or product with unknown chemical composition.
• Use of pharmacological agents known to interfere with fatigue assessment …
• Use of nutraceutical agents known to interfere with fatigue assessment …
• Agents interfering with FMD and metabolic pathways …
• Patient with medical or psychological condition, in the opinion of the investigator, preventing her from determining the study or giving meaningful informed consent.
• Patient participating in another interventional trial within 30 days prior to randomization.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

FASTEN Group

Experimental group

Description:

Participants receive standard neoadjuvant treatment plus the Fasten Onco digital therapy integrating a fasting-mimicking diet (FMD). The FMD program is synchronized with neoadjuvant treatment cycles and is supported by the Fasten Onco digital application under medical supervision.

Treatment:

Device: Fasten Onco

Standard of Care Group

Active Comparator group

Description:

Participants receive standard neoadjuvant treatment alone, without the Fasten Onco digital therapy or the fasting-mimicking diet (FMD) intervention.

Treatment:

Drug: Standard Neoadjuvant Treatment