Personalized diet may boost Well-Being in advanced cancer patients
NCT ID NCT07406789
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a personalized diet can improve quality of life in 100 women with advanced gynecologic or breast cancer who are receiving antibody-drug conjugate therapy. Participants will either follow a diet tailored to their needs or receive general Mediterranean diet advice. The goal is to see if personalized nutrition helps them feel better during treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- personalized dietary intervention
- What this could lead to
- If it works, this could show that tailoring diet to individual needs helps women with advanced cancer feel better during treatment.
- What could go wrong
- This is a small, early-phase study focused on quality of life, not survival. The diet may not provide noticeable benefits, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Hospital Universitario 12 Octubre
Madrid, Madrid, Spain
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