MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study

Conditions
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Gastric Cancer, Gastric Adenocarcinoma, Malnutrition, Cachexia

Intervention / Treatment
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* Other: Observational Survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational Survey|Evaluation of the nutritional status and body composition on tumor regression grade in gastric cancer patients scheduled for multimodal treatment. Nutritional status assessment will include: selected clinical variables evaluation (weight, BMI, nutritional status scales), bioelectrical impedance analysis and selected laboratory parameter assessment. After inclusion in the study, each patient will have four consecutive nutritional status assessments: (1) one day prior staging laparoscopy or during qualification to neoadjuvant chemotherapy, (2) one day before the gastrectomy, (3) one month after the gastrectomy, (4) after the last cycle of adjuvant chemotherapy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Regression Grade | determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response) | Up to 2-4 weeks after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neoadjuvant Chemotherapy Toxicity | evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0) | From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle | 
| Postoperative Complications | Assessed by the Comprehensive Complication Index (CCI). Min-Max values (0-100), higher scores mean a worse outcome | From date of surgery, assessed up to 90 days | 
| Overall Survival | Overall survival analysis will determine whether bioelectrical impedance analysis is a prognostic factor in advanced gastric cancer patients | From from the date of surgery to the date of patient death or the date of the last follow-up - up to 10 years | 
| Quality of Life score | Assessment based on The European Organization for Research and Treatment of Cancer quality of life, gastric-cancer specific questionnaire(EORTC QLQ - STO22). Min-Max value (1-7); higher scores mean a better outcome | From date of inclusion through study completion - an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, bioelectrical impedance analysis, body composition, nutritional status, malnutrition, cachexia, multimodal treatment, tumor regression grade