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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).

NCT07406789 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • TNC Nutrición Terapéutica S.L.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-11
Primary Completion
2028-02-11
Completion
2028-02-11

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07406789 on ClinicalTrials.gov