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Phase II, Prospective, Randomized, Proof-of-concept Study to Evaluate the Effects of a Personalized Dietary Intervention in Women With Advanced Gynecologic or Breast Tumors Treated With Antibody-Drug Conjugates (ADCs).
Sponsor: TNC Nutrición Terapéutica S.L.
Summary
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.
Official title: Phase II, Prospective, Randomized, Proof-of-Concept Study to Evaluate the Effects of a Personalized Dietary Intervention in Women With Advanced Gynecologic or Breast Tumors Treated With Antibody-Drug Conjugates (ADCs).
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-02-11
Completion Date
2028-02-11
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
Personalised dietary intervention.
Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.
General recommendations
General recommendations on the Mediterranean diet, without active dietary intervention.
Locations (1)
Hospital Universitario 12 Octubre
Madrid, Madrid, Spain