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). (LUMInova)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Breast Cancer; Gynecologic Cancers
• Intervention / Treatment: Dietary supplement: Personalised dietary intervention.; Behavioral: General recommendations

Detailed Description

Phase II, proof-of-concept, prospective, interventional, randomized, open-label study designed to evaluate the effect of a personalized dietary intervention on global quality of life in women with advanced gynecologic or breast tumors undergoing treatment with ADCs.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: TNC Nutrición Terapéutica S.L; Phone Number: +34 672 567 899; Email: info@tncterapia.com

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain
      • Hospital Universitario 12 Octubre
      • Contact: Luis David Manso, MD
      • Principal Investigator: Luis David Manso, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written informed consent to participate in the study, obtained prior to performing any specific procedure.
2. Women aged ≥ 18 years.
3. 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.
4. Participants must have received a first cycle of ADC treatment in any line of treatment.
5. ECOG performance status 0-2.
6. Availability of their main clinical data with the possibility of follow-up.

Exclusion Criteria:

1. Male patient.
2. BMI <18 or > 40 kg/m2.
3. Patients with a life expectancy of less than 3 months.
4. 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.
5. Planned participation in treatment within a double-blind clinical trial.
6. 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.
7. 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.
8. Carriers of therapeutic electronic devices: pacemakers, defibrillators, and cardiac resynchronization devices (due to potential interference caused by the wearable).
9. Patients who, in the investigator's judgment, do not possess sufficient digital capability to comply with the study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A (intervention); Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.	Dietary supplement: Personalised dietary intervention.; Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.; Other Names: Personalised diet
Active Comparator: Cohort B (Control); General recommendations on the Mediterranean diet, without active dietary intervention.	Behavioral: General recommendations; General recommendations on the Mediterranean diet, without active dietary intervention.; Other Names: Mediterranean Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate changes in mental health and psychological well-being.	Assess changes in mental health and psychological well-being using the GHQ-28 questionnaire. The assessment variable will be the change from the baseline score in the total result and in each of the subscales (somatic symptoms, anxiety/insomnia, social dysfunction, and severe depression). Patients will be classified into those with emotional distress and those without, and the evolution of the distribution will be observed throughout the follow-up.	24 months
Evaluate perceived toxicity and treatment-related symptoms.	Evaluate perceived toxicity and treatment-related symptoms through the PRO-CTCAE v5.0 questionnaire, focusing on adverse events of special interest including fatigue, nausea and vomiting, diarrhea, peripheral neuropathy, conjunctivitis, blurred vision and dry eyes, neutropenia, rash, alopecia, anemia, and hand-foot syndrome.	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess progression-free survival in real life (rwPFS)	Defined as the time from randomisation to clinical progression (based on symptomatic or radiological criteria or change in treatment due to progression) or death, whichever occurs first.	24 months

Collaborators and Investigators

• Sponsor: TNC Nutrición Terapéutica S.L.
• Collaborators: Apices Soluciones S.L.

Study record dates

Study Major Dates

• Study Start (Estimated): February 11, 2026
• Primary Completion (Estimated): February 11, 2028
• Study Completion (Estimated): February 11, 2028

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Breast cancer; Diet; Gynecologic
• Additional Relevant MeSH Terms: Neoplasms by Site; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Neoplasms; Breast Neoplasms; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Diet, Mediterranean
• Other Study ID Numbers: LMCA 001-2025 (LUMInova)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No