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

Recruiting

• Conditions: Gastric Cancer; Cachexia; Gastric Adenocarcinoma; Malnutrition

• Registration Number: NCT05723718
• Lead Sponsor: Medical University of Lublin

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.

Study Timeline

• Study Start: 2022-12-20
• Study First Submitted: 2023-01-24
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Study First Posted: 2023-02-13
• Last Update Posted: 2023-02-13
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Medical University of Lublin; 🇵🇱 Lublin, Poland