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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).

Study acronym: LUMInova
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Primary and study completion dates: Feb 11, 2028 to Mar 10, 2028 · Start date changed from estimate of Feb 11, 2026 to Mar 10, 2026 · Eligibility criteria expanded, about 13 words · 2 more Show 5 more changesShow less
    • Primary and study completion dates: Feb 11, 2028 to Mar 10, 2028
    • Start date changed from estimate of Feb 11, 2026 to Mar 10, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07406789
Lead Sponsor TNC Nutrición Terapéutica S.L.
Collaborators: Apices Soluciones S.L.
Conditions Gynecologic Cancers, Advanced Breast Cancer
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov