MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment
MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study
Medical University of Lublin
125 participants
Dec 20, 2022
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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)
Interventions
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.
Locations(1)
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NCT05723718