Actively Recruiting
Led by Medical University of Lublin · Updated on 2023-02-13
125
Participants Needed
1
Research Sites
N/A
Total Duration
M
Medical University of Lublin
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
Researchers are studying how nutritional status and body composition affect tumor regression in patients with gastric cancer undergoing multimodal treatment. This observational study aims to determine if bioelectrical impedance analysis, a non-invasive method for measuring body composition, can be used as a reliable tool to support clinical decisions for these patients. The study involves patients with locally advanced gastric adenocarcinoma who are scheduled to receive multimodal therapy. The study will include 125 patients who will each have their nutritional status assessed four times at specific points during their treatment: before staging laparoscopy or chemotherapy qualification, before gastrectomy surgery, one month after surgery, and after completing adjuvant chemotherapy. Assessments will include clinical variables such as weight and BMI, bioelectrical impedance analysis, and laboratory tests. Participants will be monitored for tumor regression grade up to 2-4 weeks after surgery. Additional outcomes include chemotherapy toxicity, postoperative complications, overall survival up to 10 years, and quality of life over about three years. The study involves multiple evaluations to track changes in nutritional status and body composition throughout the treatment period, helping researchers understand their impact on treatment outcomes.
CONDITIONS
MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From inclusion through completion of multimodal treatment
Participants undergo four nutritional status assessments including weight, BMI, nutritional status scales, bioelectrical impedance analysis, and laboratory parameters throughout their multimodal treatment.
4 visits corresponding to (1) prior to staging laparoscopy or neoadjuvant chemotherapy qualification, (2) one day before gastrectomy, (3) one month after gastrectomy, and (4) after the last cycle of adjuvant chemotherapy
Duration - Up to 10 years
Participants are observed for overall survival and quality of life following surgery and multimodal treatment.
Visits scheduled as part of routine follow-up care
Total: 1 location
1
Medical University of Lublin
Lublin, Poland, 20-080
Actively Recruiting
Z
Zuzanna Pelc, PhD
K
Karol Rawicz-Pruszyński, Professor
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Zuzanna Pelc, Katarzyna Sędłak, Radosław Mlak...
https://pubmed.ncbi.nlm.nih.gov/38319910