NCT07059598已完成不适用
Evaluate the Relationship of Nutritional Status to Chemotherapy Treatment Completion Rates and Outcomes in Real-life Conditions in Patients With Metastatic and Non-metastatic Gastric, Colon, and Lung Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 13
- 主要终点
- RMAPP
研究概览
简要总结
This non-interventional, prospective, non-drug observational study is designed to observe the effect of the nutritional status of metastatic and non-metastatic gastric, colon and lung cancer patients on their cancer chemotherapy treatment completion rates.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject or subject's legally acceptable representative (LAR) has voluntarily signed and dated an ICF approved by an IEC, or any other applicable privacy authorization prior to any participation in the study.
- •Ambulatory and inpatient subject.
- •Subject recently (within the last month) or newly diagnosed to have metastatic or non-metastatic gastric, colon and lung cancer.
- •Subject is recently receiving chemotherapy or recently prescribed to begin chemotherapy treatment per standard of care (within the last month) or candidates who will receive chemotherapy.
- •Subject has a life expectancy greater than 6 months.
排除标准
- •Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, any other psychological condition, serious illness or medical condition that may interfere with study completion.
- •Subject has malignant tumors other than treated DCIS, fully treated non-melanoma skin cancer, curatively resected in-situ cervical cancer or other curative treated tumors (except stomach, colon and lung cancer) for > 5 years.
- •Subject has bone marrow metastasis.
- •Subject is lactating.
- •Subject is participating in another study that has not been approved as a concomitant study.
结局指标
主要结局
RMAPP
时间窗: Baseline to week 24
A tool to screen patients for risk of malnutrition and/or sarcopenia
PG-SGA
时间窗: Baseline to week 24
Healthcare Professional completed assessment resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished
次要结局
- Weight(Baseline to 24 weeks)
- Height(Baseline)
- Calf Circumference(Baseline to 24 weeks)
- Fat Free Mass Index(Baseline to week 24)
- EORTC QLQ-C30(Baseline to 12 months)
- Body Mass Index(Baseline to week 24)
- Handgrip Strength(Baseline to 24 weeks)
- Walking Speed(Baseline to 24 weeks)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
不适用
Observational Study at the Influence of Malnutrition on InfectionsMalnutritionNCT01243528Marion Mertl-Roetzer100
尚未招募
不适用
A study to assess the effect of food formulation in patients with chronic obstructive pulmonary diseaseChronic Obstructive Pulmonary DiseaseCTRI/2017/09/009883University Grants Commission40
招募中
不适用
Exploratory study of nutritional status influenced by correlation between pancreas and small intestineDigestive diseases with a focus on pancreatic diseaseJPRN-UMIN000014200agoya University Graduate School of Medicine300
已完成
不适用
An exploratory study into the effects of nutritional supplementation on skeletal muscle preservation during a weight loss program in elderlyobesitasAdiposityoverweightNL-OMON34540Vrije Universiteit Medisch Centrum80
尚未招募
Unknown
Above study will provide the relationship among nutritional status and psychological variables in Hemodialysis patientsCTRI/2024/05/067857AIIMS NEW DELHI