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 | Not Yet Recruiting Phase 2

• 1 other identifier: LMCA 001-2025 (LUMInova)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Gynecologic Cancers; Advanced Breast Cancer

Keywords

Breast cancer; Diet; Cancer; Gynecologic

Outcome Measures

Primary Outcomes (1)

• 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.

  Quality of life will be measured using the validated EORTC QLQ-C30 questionnaire, considering as the primary variable the percentage of patients experiencing clinically relevant improvement, defined as an increase of ≥10 points in the overall score from baseline.

  24 months

Secondary Outcomes (2)

• Evaluate changes in mental health and psychological well-being.

  24 months

• Evaluate perceived toxicity and treatment-related symptoms.

  24 months

Other Outcomes (1)

• Assess progression-free survival in real life (rwPFS)

  24 months

Study Arms (2)

Cohort A (intervention)

EXPERIMENTAL

Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.

Dietary Supplement: Personalised dietary intervention.

Cohort B (Control)

ACTIVE COMPARATOR

General recommendations on the Mediterranean diet, without active dietary intervention.

Behavioral: General recommendations

Interventions

Personalised dietary intervention. DIETARY_SUPPLEMENT

Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.

Also known as: Personalised diet

Cohort A (intervention)

General recommendations BEHAVIORAL

General recommendations on the Mediterranean diet, without active dietary intervention.

Also known as: Mediterranean Diet

Cohort B (Control)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Confirmed diagnosis of advanced, incurable (stage IV or unresectable stage III) breast cancer or gynecologic cancer. This includes cancers of the breast, ovary, cervix, uterus, endometrium, fallopian tubes, vagina, or vulva.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 breast, ovary, cervix, uterus, endometrium, fallopian tubes, vagina, or vulva.
• Participants must have received a first cycle of ADC treatment in any line of treatment.
• ECOG performance status 0-2.
• Availability of their main clinical data with the possibility of follow-up.

You may not qualify if:

• Male patient.
• BMI \<18 or \> 40 kg/m2.
• Patients with a life expectancy of less than 3 months.
• Type 1 diabetes mellitus, metabolic diseases, and severe gastrointestinal disorders that interfere with the digestion or absorption of nutrients, as well as patients with severe renal or hepatic impairment.
• Planned participation in treatment within a double-blind clinical trial.
• History of previous or concomitant malignant disease of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or in situ cervical cancer are eligible for the study.
• Presence of concurrent diseases or clinical conditions that, in the investigator's judgment, may significantly interfere with participation in the study, particularly those that limit the ability to adequately use the required digital tools (APP and wearable device). Patients will not be excluded due to common comorbidities if they retain adequate cognitive functioning and digital familiarity to comply with study procedures.
• Carriers of therapeutic electronic devices: pacemakers, defibrillators, and cardiac resynchronization devices (due to potential interference caused by the wearable).
• Patients who, in the investigator's judgment, do not possess sufficient digital capability to comply with the study procedures.

Sponsors & Collaborators

• TNC Nutrición Terapéutica S.L.: lead
• Apices Soluciones S.L.: collaborator

Study Sites (1)

Hospital Universitario 12 Octubre

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

TNC Nutrición Terapéutica S.L

CONTACT

+34 672 567 899; info@tncterapia.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): February 11, 2028
• Study Completion (Estimated): February 11, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

ES (1)