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

Medical University of Lublin

Status: Enrolling

Conditions: Malnutrition; Gastric Cancer; Cachexia; Gastric Adenocarcinoma

Treatments: Other: Observational Survey

Study type: Observational

Funder types: Other

Identifiers

NCT05723718

MOONRISE_2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)