PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy

Официальное название

PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving First-line Platinum-based Chemotherapy

Обзор

Open clinical trial addressing the effect of a nutritional support based on whey proteins, leucine and vitamin D on muscle mass and multiple anticancer treatment-related endpoints in patients with gynecologic cancer receiving first-line platinum-based chemotherapy (adjuvant or curative). A comparison to matched historical controls will be performed to address potential evidence of efficacy to be investigated in a subsequent randomized trial.

Вмешательства

• Пищевая добавка Experimental product - Fortifit® Powder
  Two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
• Другое Standard of care
  Control group receiving no nutritional intervention or on-demand non muscle-targeted intervention such as nutritional counseling with or without oral nutritional supplement

Первичные конечные точки

• Change in muscle mass area [Срок оценки: 18 weeks]

Вторичные конечные точки (9)

• Skeletal muscle mass [Срок оценки: 18 weeks]
• Body weight [Срок оценки: 18 weeks]
• Protein-calorie intake [Срок оценки: 18 weeks]
• Handgrip strength [Срок оценки: 18 weeks]
• Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0] [Срок оценки: 18 weeks]
• Adherence to treatment schedule [Срок оценки: 18 weeks]
• Total dose of chemotherapy administered [Срок оценки: 18 weeks]
• Patients requiring unplanned hospitalization [Срок оценки: 18 weeks]
• Tolerance to nutritional support [Срок оценки: 18 weeks]

Критерии участия

Критерии включения

• histologically confirmed diagnosis of gynecologic cancer (ovarian, uterine, cervical);
• indication for a first-line chemotherapy (adjuvant or curative) with a platinum-based regimen to be used by investigator's choice within the framework of good clinical practice and in agreement with current Italian Association of Medical Oncology guidelines;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
• signed informed consent.

Критерии исключения

• age <18 years
• ECOG performance status >2
• indication to or ongoing artificial nutrition support
• known kidney failure (previous glomerular filtration rate <30 ml/min);
• known liver failure (Child B or C)
• endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
• decompensated diabetes
• indications related to the study product: more than 10 µg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources; adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
• known allergy to milk, milk products or other components of the proposed interventions
• inclusion in other nutritional intervention trials
• patients refusal

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS San Matteo — Pavia

Идентификаторы

NCT: NCT06087783 · 0014137/23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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