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

Sponsor

Medical University of Lublin (Other)

Overall Status

Recruiting

CT.gov ID

NCT05723718

Collaborator

Erasmus Medical Center (Other), Ohio State University (Other), Poznan University of Medical Sciences (Other), Jagiellonian University (Other)

125

Enrollment

Location

72.4

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Gastric Adenocarcinoma Malnutrition Cachexia	Other: Observational Survey

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

125 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study

Actual Study Start Date :

Dec 20, 2022

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2028

Outcome Measures

Primary Outcome Measures

Tumor Regression Grade [Up to 2-4 weeks after the surgery]
determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)

Secondary Outcome Measures

Neoadjuvant Chemotherapy Toxicity [From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle]
evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0)
Postoperative Complications [From date of surgery, assessed up to 90 days]
Assessed by the Comprehensive Complication Index (CCI). Min-Max values (0-100), higher scores mean a worse outcome
Overall Survival [From from the date of surgery to the date of patient death or the date of the last follow-up - up to 10 years]
Overall survival analysis will determine whether bioelectrical impedance analysis is a prognostic factor in advanced gastric cancer patients
Quality of Life score [From date of inclusion through study completion - an average of 3 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma)
Stage II - III disease (cT2 cN+ and cT3-T4 cN+/-) based on the 8th edition of TNM classification
Qualification for multimodal treatment by the decision of the multidisciplinary tumor board

Exclusion Criteria:

Early gastric cancer (cT1N0-3M0) scheduled for endoscopic treatment by multidisciplinary team
Gastric stump carcinoma
Distant metastasis
Upfront surgery
Other malignancies
Contraindications to bioelectrical impedance analysis (e.g., implanted cardiac devices, metal implants or pregnancy)