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.
Study ID
NCT07406789
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Breast Cancer
  • Gynecologic Cancers

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 12, 2026
Start date
Feb 11, 2026
Status verified
Feb 2026
Primary completion
Feb 11, 2028
Completion
Feb 11, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cohort A (intervention)
    Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.
  • Active Comparator: Cohort B (Control)
    General recommendations on the Mediterranean diet, without active dietary intervention.

Primary Outcome Measure

Evaluate the effect of a personalized dietary intervention on health-related quality of life (HRQoL), compared with general recommendations for a Mediterranean diet, in women with advanced gynecologic or breast tumors treated with ADCs. [ Time Frame: 24 months ]

Central Contacts

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