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).

Официальное название

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).

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Personalised dietary intervention.
  Personalised dietary intervention, tailored to clinical and metabolic parameters and individual preferences.
• Поведенческое General recommendations
  General recommendations on the Mediterranean diet, without active dietary intervention.

Первичные конечные точки

• 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. [Срок оценки: 24 months]

Вторичные конечные точки (2)

• Evaluate changes in mental health and psychological well-being. [Срок оценки: 24 months]
• Evaluate perceived toxicity and treatment-related symptoms. [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Испания · 1 центр

• Hospital Universitario 12 Octubre — Madrid

Идентификаторы

NCT: NCT07406789 · LMCA 001-2025 (LUMInova)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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