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

February 9, 2023 updated by: Medical University of Lublin

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 2-4 weeks after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle
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
From date of surgery, assessed up to 90 days
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
From from the date of surgery to the date of patient death or the date of the last follow-up - up to 10 years
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
From date of inclusion through study completion - an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Collaborators

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

Investigators

  • Principal Investigator: Zuzanna Pelc, PhD, Medical University of Lublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 20, 2022

Primary Completion (ANTICIPATED)

December 31, 2028

Study Completion (ANTICIPATED)

December 31, 2028

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (ACTUAL)

February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOONRISE_2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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