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NCT Number: NCT05723718

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

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.

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Key information

Conditions

Gastric Cancer Body Weight Body Weight Changes Cachexia Digestive System Diseases Digestive System Neoplasms Gastric Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases Stomach Neoplasms Thinness Weight Loss

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Lublin

Lublin, 20-080, Poland

Location status: Recruiting

Location contact

Karol RawiczPruszyński, Professor

CONTACT

[email protected]

81 531 81 26

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Observational Survey

Other

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.

Other names: Nutritional Status and Body Composition Assessment

Primary outcomes

  1. Tumor Regression Grade

    Time frame: 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 outcomes

  1. Neoadjuvant Chemotherapy Toxicity

    Time frame: 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)

  2. Postoperative Complications

    Time frame: 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

  3. Overall Survival

    Time frame: 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

  4. Quality of Life score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Karol Rawicz-Pruszyński, Professor

CONTACT

[email protected]

+48 81 531 81 26

Zuzanna Pelc, PhD

CONTACT

[email protected]

+48 81 531 81 26

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Collaborators

  • Erasmus Medical Center
  • Jagiellonian University
  • Ohio State University
  • Poznan University of Medical Sciences

Registry information

Official study title

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

Acronym: MOONRISE

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2023
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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