NCT05938504招募中不适用
Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy: Randomized, Parallel, Double-blind, Placebo-controlled Trial
Daesang Wellife2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2023年3月14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
- 154
- 试验地点
- 2
- 主要终点
- Skeletal Muscle Index (SMI) change rate
研究概览
简要总结
The goal of this clinical trial is to find usefulness of balanced high protein supplementation on muscle function recovery and clinical outcomes after chemotherapy.
Participants will intake test or placebo oral nutritional supplements. Researchers will compare test groups and placebo groups to see if test oral supplements are more useful in muscle function recovery and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person aged 19 or older
- •A person who is diagnosed with direct colorectal cancer and begins chemotherapy
- •A person who voluntarily agreed to participate in this trial and signed a informed consent form
排除标准
- •A person who has previously been diagnosed with cancer
- •A person with a BMI of 30.0 kg/m2 or more
- •A person who is diabetes mellitus with whose blood sugar is not controlled even when taking medication
- •More than 126mg/dL of fasting blood sugar even on diabetes medication
- •A person diagnosed with hypertension whose blood pressure is not controlled even when taking medication
- •Systolic blood pressure 160mmHg or diastolic blood pressure 100mmHg or higher even when taking hypertension medication
- •A person with renal dysfunction (up 1.5 times the upper limit of Creatinine normal) and liver dysfunction (up 2.5 times the upper limit of AST and ALT normal)
- •A person with a serious musculoskeletal problem
- •A person who has been diagnosed with acute or serious diseases (e.g., liver, kidney, heart, thyroid disease, etc.) or is on medication
- •A person who has continuously taken health functional foods related to the ability to perform exercise within three months before visiting (Hormones, muscle enhancers, protein supplementation and muscle function improvement)
- •A person who is allergic or overreacting to the ingredients of a test product
- •All ingredients of the test product shall be specified in the consent form, and all ingredients that may cause allergies, such as sodium casein, shall be checked during screening
- •A person who has participated in another clinical trial or a drug clinical trial within one month of the commencement of this test
- •A person who is illiterate or whose ability is limited
- •A person who is pregnant or lactating
- •A person judged inappropriate by a researcher to participate in this study for other reasons
结局指标
主要结局
Skeletal Muscle Index (SMI) change rate
时间窗: Change rate from baseline Skeletal Muscle Index (SMI) at 12 weeks
Skeletal Muscle analysis is performed using BIA.
次要结局
- Sarcopenia prevalence(Change from baseline Muscle reduction at 12 weeks)
- Skeletal muscle mass (SMM)(Change from baseline Skeletal muscle mass (SMM) at 12 weeks)
- Handgrip strength (HGS)(Change from baseline Handgrip strength (HGS) at 12 weeks)
- Short physical performance battery (SPPB)(Change from baseline Short physical performance battery (SPPB) at 12 weeks)
- Common terminology criteria for adverse events (CTCAE) 5.0(Evaluating from 6 weeks to 12 weeks)
- Incidence of chemotherapy modification(Evaluating from 6 weeks to 12 weeks)
- Weight change and weight change rate(Change from baseline weight change and weight change rate at 12 weeks)
- Detection of immunity indicators in blood samples drawn from a vein(Change from baseline immunity indicators at 12 weeks)
- Nutritional status evaluation and intake evaluation (PG-SGA)(Change from baseline PG-SGA score at 12 weeks)
- Quality of life (EORTC QLQ-C30)(Change from baseline EORTC QLQ-C30 score at 12 weeks)
- Simplified nutritional appetite questionnaire (SNAQ)(Change from baseline SNAQ score at 12 weeks)
- Oral nutritional supplement (ONS) sensory evaluation(Evaluating from 6 weeks to 12 weeks)
研究者
研究点 (2)
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