NCT06087783招募中不适用
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving First-line Platinum-based Chemotherapy
Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in muscle mass area
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in muscle mass area
时间窗: 18 weeks
Change in muscle mass at the end of first-line platinum-based chemotherapy (adjuvant or curative) evaluated with computed tomography scan at the level of the third lumbar vertebra
次要结局
- Skeletal muscle mass(18 weeks)
- Adherence to treatment schedule(18 weeks)
- Body weight(18 weeks)
- Protein-calorie intake(18 weeks)
- Handgrip strength(18 weeks)
- Total dose of chemotherapy administered(18 weeks)
- Patients requiring unplanned hospitalization(18 weeks)
- Tolerance to nutritional support(18 weeks)
- Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0](18 weeks)
研究者
Emanuele Cereda
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (2)
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