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).

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 ID
NCT07406789
Phase
PHASE2
Sponsor
TNC Nutrición Terapéutica S.L.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Personalised dietary intervention.
  • General recommendations
Locations (sample)
  • Madrid, Madrid, Spain|40.4165,-3.70256

Key Eligibility Criteria

  • Written informed consent to participate in the study, obtained prior to performing any specific procedure.
  • Women aged ≥ 18 years.
  • Confirmed diagnosis of advanced, incurable (stage IV or unresectable stage III) breast cancer or gynecologic cancer. This includes cancers of the b…
  • Participants must have received a first cycle of ADC treatment in any line of treatment.

For full eligibility, visit ClinicalTrials.gov.

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