MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Tumor Regression Grade
研究概览
简要总结
The aim of this single-arm prospective, multicenter, cross-sectional study is to evaluate the nutritional status and body composition on tumor regression grade with bioelectrical impedance analysis in gastric cancer patients undergoing multimodal treatment. Results of this study will reveal whether nutritional status and body composition assessment based on bioelectrical impedance analysis will become a validated and objective tool to support clinical decisions in gastric cancer patients undergoing multimodal treatment.
详细描述
Up to 20% of gastric cancer patients experience unintentional loss of their pretreatment body weight. Malnutrition contributes to increased morbidity, higher risk of perioperative complications and systemic toxicity. A standardized approach to evaluate the nutritional status of gastric cancer patients is yet to be established. Bioelectrical impedance analysis is a non-invasive technique estimating changes in body composition over time.
125 patients with locally advanced gastric adenocarcinoma scheduled for multimodal treatment will be included in the study. Four consecutive nutritional status assessments will be performed throughout the treatment.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma)
- •Stage II - III disease (cT2 cN+ and cT3-T4 cN+/-) based on the 8th edition of TNM classification
- •Qualification for multimodal treatment by the decision of the multidisciplinary tumor board
排除标准
- •Early gastric cancer (cT1N0-3M0) scheduled for endoscopic treatment by multidisciplinary team
- •Gastric stump carcinoma
- •Distant metastasis
- •Upfront surgery
- •Other malignancies
- •Contraindications to bioelectrical impedance analysis (e.g., implanted cardiac devices, metal implants or pregnancy)
结局指标
主要结局
Tumor Regression Grade
时间窗: Up to 2-4 weeks after the surgery
determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)
次要结局
- Neoadjuvant Chemotherapy Toxicity(From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle)
- Postoperative Complications(From date of surgery, assessed up to 90 days)
- Quality of Life score(From date of inclusion through study completion - an average of 3 years)
- Overall Survival(From from the date of surgery to the date of patient death or the date of the last follow-up - up to 10 years)