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Trial Title:
MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment
NCT ID:
NCT05723718
Condition:
Gastric Cancer
Gastric Adenocarcinoma
Malnutrition
Cachexia
Conditions: Official terms:
Stomach Neoplasms
Malnutrition
Wasting Syndrome
Cachexia
Conditions: Keywords:
gastric cancer
bioelectrical impedance analysis
body composition
nutritional status
malnutrition
cachexia
multimodal treatment
tumor regression grade
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Observational Survey
Description:
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.
Other name:
Nutritional Status and Body Composition Assessment
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
This study will include a western population of patients with histologically confirmed,
potentially curative esophageal gastro junction and gastric adenocarcinoma scheduled for
multimodal treatment.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma)
3. Stage II - III disease (cT2 cN+ and cT3-T4 cN+/-) based on the 8th edition of TNM
classification
4. Qualification for multimodal treatment by the decision of the multidisciplinary
tumor board
Exclusion Criteria:
1. Early gastric cancer (cT1N0-3M0) scheduled for endoscopic treatment by
multidisciplinary team
2. Gastric stump carcinoma
3. Distant metastasis
4. Upfront surgery
5. Other malignancies
6. Contraindications to bioelectrical impedance analysis (e.g., implanted cardiac
devices, metal implants or pregnancy)
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical University of Lublin
Address:
City:
Lublin
Zip:
20-080
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Karol RawiczPruszyński, Professor
Phone:
81 531 81 26
Email:
karol.rawicz-pruszynski@umlub.pl
Start date:
December 20, 2022
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Medical University of Lublin
Agency class:
Other
Collaborator:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Ohio State University
Agency class:
Other
Collaborator:
Agency:
Poznan University of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Jagiellonian University
Agency class:
Other
Source:
Medical University of Lublin
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05723718
