Clinical trial NCT05723718: MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment
Official title: MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Gastric Adenocarcinoma
Malnutrition
Cachexia
Keywords: gastric cancer
bioelectrical impedance analysis
body composition
nutritional status
malnutrition
cachexia
multimodal treatment
tumor regression grade
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Ohio State University
name: Poznan University of Medical Sciences
name: Jagiellonian University
First posted: 2023-02-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include a western population of patients with histologically confirmed, potentially curative esophageal gastro junction and gastric adenocarcinoma scheduled for multimodal treatment.

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Tumor Regression Grade
timeFrame: Up to 2-4 weeks after the surgery
Secondary outcomes:
measure: Neoadjuvant Chemotherapy Toxicity
timeFrame: From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle
measure: Postoperative Complications
timeFrame: From date of surgery, assessed up to 90 days
measure: Overall Survival
timeFrame: From from the date of surgery to the date of patient death or the date of the last follow-up - up to 10 years
measure: Quality of Life score
timeFrame: From date of inclusion through study completion - an average of 3 years
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Medical University of Lublin
Study officials:
affiliation: Medical University of Lublin
name: Zuzanna Pelc, PhD
role: PRINCIPAL_INVESTIGATOR
References: