A Phase 2 interventional study of Personalised dietary intervention. and General recommendations in Gynecologic Cancers and Advanced Breast Cancer, sponsored by TNC Nutrición Terapéutica S.L.. Not yet recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by TNC Nutrición Terapéutica S.L. · Phase 2, Interventional, and Other
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.
Phase II, proof-of-concept, prospective, interventional, randomized, open-label study designed to evaluate the effect of a personalized dietary intervention on global quality of life in women with advanced gynecologic or breast tumors undergoing treatment with ADCs.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with TNC Nutrición Terapéutica S.L. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.
Dietary Supplement: Personalised dietary intervention.
General recommendations on the Mediterranean diet, without active dietary intervention.
Behavioral: General recommendations
Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.
Also known as: Personalised diet
General recommendations on the Mediterranean diet, without active dietary intervention.
Also known as: Mediterranean Diet
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 months
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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