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

Prior treatment

• Patient with prior breast cancer (invasive or non-invasive breast cancer).
• 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.
• 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).
• Patient participating in another interventional trial within 30 days prior to randomization.

Other illness

• 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 food allergies.
• Patient with metabolic disorders affecting gluconeogenesis or adaptation to short periods of fasting.
• Patient with behavioral eating disorders.
• Patient with medical or psychological condition, in the opinion of the investigator, preventing her from determining the study or giving meaningful informed consent.

Other

• 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 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 already following a fasting or fasting mimicking diet.
• 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 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.