The objective of the study is to evaluate the effect of a personalized dietary intervention (cohort A), compared with a standard nutritional intervention based on general recommendations for following a Mediterranean diet (cohort B), in women with advanced solid tumors of gynecologic or breast origin who are receiving treatment with antibody-drug conjugates (ADCs). This intervention is exclusively nutritional and does not involve the use of any investigational drug.
Written informed consent to participate in the study, obtained prior to performing any specific procedure.
Women aged ≥ 18 years.
Confirmed diagnosis of advanced, incurable (stage IV or unresectable stage III) breast cancer or gynecologic cancer. This includes cancers of the breast, ovary, cervix, uterus, endometrium, fallopian tubes, vagina, or vulva.
Participants must have received a first cycle of ADC treatment in any line of treatment.
Male patient.
BMI <18 or > 40 kg/m2.
Patients with a life expectancy of less than 3 months.
Type 1 diabetes mellitus, metabolic diseases, and severe gastrointestinal disorders that interfere with the digestion or absorption of nutrients, as well as patients with severe renal or hepatic impairment.
TNC Nutrición Terapéutica S.L.
Lead sponsor
Apices Soluciones S.L.
Collaborator