Gynecologic CancersPhase 2LUMInovaNCT07406789
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).
A Phase 2 study testing Personalised dietary intervention. and General recommendations in people with Gynecologic Cancers and Advanced Breast Cancer, run by TNC Nutrición Terapéutica S.L. at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancers, Advanced Breast Cancer
- What is being tested?
- Personalised dietary intervention. and General recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2026to 10 Mar 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 Octubre
Madrid, Madrid
Luis Manso, MD
Luis Manso, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Gynecologic Cancers, Advanced Breast Cancer
- Being tested
- Personalised dietary intervention., General recommendations
- Keywords
- Breast cancer, Diet, Cancer, Gynecologic
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised dietary intervention.Dietary supplement
Also called Personalised diet
Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.
General recommendationsBehavioural
Also called Mediterranean Diet
General recommendations on the Mediterranean diet, without active dietary intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (intervention) | Experimental | Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences. Receives: Dietary Supplement: Personalised dietary intervention. |
| Cohort B (Control) | Active comparator | General recommendations on the Mediterranean diet, without active dietary intervention. Receives: Behavioral: General recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start10 Mar 2026
- Primary completion10 Mar 2028 (estimated)
- Study completion10 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TNC Nutrición Terapéutica S.L.
- Sponsor type
- University, hospital or other
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406789
- Sponsor's protocol ID
- LMCA 001-2025 (LUMInova)
- Acronym
- LUMInova
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No