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.
Parallel
Personalised dietary intervention.
Dietary supplementPersonalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.
General recommendations
BehavioralGeneral recommendations on the Mediterranean diet, without active dietary intervention.
Evaluate the effect of a personalized dietary intervention on health-related quality of life (HRQoL), compared with general recommendations for a Mediterranean diet, in women with advanced gynecologic or breast tumors treated with ADCs.
Quality of life will be measured using the validated EORTC QLQ-C30 questionnaire, considering as the primary variable the percentage of patients experiencing clinically relevant improvement, defined as an increase of ≥10 points in the overall score from baseline.
Evaluate changes in mental health and psychological well-being.
Assess changes in mental health and psychological well-being using the GHQ-28 questionnaire. The assessment variable will be the change from the baseline score in the total result and in each of the subscales (somatic symptoms, anxiety/insomnia, social dysfunction, and severe depression). Patients will be classified into those with emotional distress and those without, and the evolution of the distribution will be observed throughout the follow-up.
Evaluate perceived toxicity and treatment-related symptoms.
Evaluate perceived toxicity and treatment-related symptoms through the PRO-CTCAE v5.0 questionnaire, focusing on adverse events of special interest including fatigue, nausea and vomiting, diarrhea, peripheral neuropathy, conjunctivitis, blurred vision and dry eyes, neutropenia, rash, alopecia, anemia, and hand-foot syndrome.
Assess progression-free survival in real life (rwPFS)
Defined as the time from randomisation to clinical progression (based on symptomatic or radiological criteria or change in treatment due to progression) or death, whichever occurs first.
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TNC Nutrición Terapéutica S.L.
Lead sponsor
Apices Soluciones S.L.
Collaborator
