NCT05648955招募中早期 1 期
Muscle Mass in Patients With Colorectal or Lung Cancer When Receiving an Oral Nutritional Supplement During Anti-cancer Treatment
Nutricia Research1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2023年3月31日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2]
研究概览
简要总结
Malnutrition and low muscle mass (sarcopenia) are common problems in patients with cancer. However, a low muscle mass is associated with negative clinical outcomes in patients with cancer. Therefore, it is very important to maintain muscle mass in this population. This study aims to investigate the effect of an oral nutritional supplement on skeletal muscle mass during anti-cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage III or IV colorectal or non-small cell lung cancer
- •Scheduled for the first cycle of any line of a systemic treatment: chemotherapy, concurrent chemoradiotherapy, immunotherapy or targeted treatment with a planned duration of at least 9 weeks
- •Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- •Age ≥ 18 years
排除标准
- •Weight loss >10% in the last 6 months
- •Body Mass Index > 30.0 kg/m2
- •Life expectancy < 3 months
- •Receiving enteral (tube) or parenteral nutrition
- •Presence of ileostoma or ileal pouch (except for an ileostomy at or near the terminal ileum which does not affect absorption of nutrients other than sodium, potassium, and water, in the opinion of the investigator)
- •Allergy to cow's milk protein, soy or fish, requiring a fibre-free diet or suffering galactosemia or lactose intolerance
- •Known pregnancy or lactation
- •Current alcohol or drug abuse in the opinion of the investigator
- •Wearing an electronic implant and/or pacemaker
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- •Participation in any other studies involving investigational or marketed products concomitantly or within 14 days prior to entry into the study
结局指标
主要结局
Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2]
时间窗: 12 weeks
between baseline and after 12 weeks of intervention as measured with a CT scan, between the two interventions
次要结局
- Change in health-related quality of life as measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30 global health score)(~13 weeks)
研究者
研究点 (1)
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