Personalized diet to help women with advanced gynecologic or breast cancer on ADC therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, randomized, open-label study compares a personalized dietary intervention to standard Mediterranean-diet guidance in women with advanced gynecologic or breast tumors receiving antibody-drug conjugates. The primary focus is on global quality of life, with nutrition as the exclusive intervention and no investigational drugs involved. Eligible participants are adults with confirmed advanced cancers, who have started an ADC treatment, and meet health status criteria. Enrollment is at a single center in Madrid, with sponsors TNC Nutrición Terapéutica and Apices Soluciones as collaborators. The trial aims to generate proof-of-concept data on whether tailored nutrition can benefit patients during ADC therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent to participate in the study, obtained prior to performing any specific procedure.
2. Women aged ≥ 18 years.
3. 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.
4. Participants must have received a first cycle of ADC treatment in any line of treatment.
5. ECOG performance status 0-2.
6. Availability of their main clinical data with the possibility of follow-up.

Exclusion Criteria:

1. Male patient.
2. BMI \<18 or \> 40 kg/m2.
3. Patients with a life expectancy of less than 3 months.
4. 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.
5. Planned participation in treatment within a double-blind clinical trial.
6. History of previous or concomitant malignant disease of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or in situ cervical cancer are eligible for the study.
7. Presence of concurrent diseases or clinical conditions that, in the investigator's judgment, may significantly interfere with participation in the study, particularly those that limit the ability to adequately use the required digital tools (APP and wearable device). Patients will not be excluded due to common comorbidities if they retain adequate cognitive functioning and digital familiarity to comply with study procedures.
8. Carriers of therapeutic electronic devices: pacemakers, defibrillators, and cardiac resynchronization devices (due to potential interference caused by the wearable).
9. Patients who, in the investigator's judgment, do not possess sufficient digital capability to comply with the study procedures.

Where it's running

• Hospital Universitario 12 Octubre
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: TNC Nutrición Terapéutica S.L
• Email: info@tncterapia.com
• Phone: +34 672 567 899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.