NCT07406789

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).

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).

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: TNC Nutrición Terapéutica S.L. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Gynecologic Cancers
• Advanced Breast Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Personalised dietary intervention.	Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.
BEHAVIORAL	General recommendations	General recommendations on the Mediterranean diet, without active dietary intervention.

Timeline

• Start date: 2026-02-11
• Primary completion: 2028-02-11
• Completion: 2028-02-11
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: Spain