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

Gastric Cancer Clinical Trial

— MOONRISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723718
• Other study ID #: MOONRISE_2023
• Status: Recruiting
• Start date: December 20, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2023
• Source: Medical University of Lublin
• Contact: Zuzanna Pelc, PhD
• Phone: +48 81 531 81 26
• Email: zuzannapelc[@]umlub.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cachexia
• Gastric Adenocarcinoma
• Gastric Cancer
• Malnutrition
• Stomach Neoplasms

Intervention

Other:
• Observational Survey
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.

Locations

Country	Name	City	State
Poland	Medical University of Lublin	Lublin

Sponsors (5)

Lead Sponsor	Collaborator
Medical University of Lublin	Erasmus Medical Center, Jagiellonian University, Ohio State University, Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Regression Grade	determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)	Up to 2-4 weeks after the surgery
Secondary	Neoadjuvant Chemotherapy Toxicity	evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0)	From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle
Secondary	Postoperative Complications	Assessed by the Comprehensive Complication Index (CCI). Min-Max values (0-100), higher scores mean a worse outcome	From date of surgery, assessed up to 90 days
Secondary	Overall Survival	Overall survival analysis will determine whether bioelectrical impedance analysis is a prognostic factor in advanced gastric cancer patients	From from the date of surgery to the date of patient death or the date of the last follow-up - up to 10 years
Secondary	Quality of Life score	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	From date of inclusion through study completion - an average of 3 years