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.
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.
Study Type
OBSERVATIONAL
Enrollment
125
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.
Medical University of Lublin
Lublin, Poland
RECRUITINGTumor Regression Grade
determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)
Time frame: Up to 2-4 weeks after the surgery
Neoadjuvant Chemotherapy Toxicity
evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From date of inclusion through study completion - an average of 3 years
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