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

Ki vehet részt

• - 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

Ki nem vehet részt

• 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
• 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
• 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 …