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

ConditionsGastric CancerGastric AdenocarcinomaMalnutritionCachexia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorMedical University of Lublin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Early gastric cancer (cT1N0-3M0) scheduled for endoscopic treatment by multidisciplinary team

Gastric stump carcinoma

Distant metastasis

Upfront surgery

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational Survey

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Tumor Regression Grade

determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)

Time frame
Up to 2-4 weeks after the surgery

Secondary outcomes

1

Neoadjuvant Chemotherapy Toxicity

evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0)

Time frame
From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle
2

Postoperative Complications

Assessed by the Comprehensive Complication Index (CCI). Min-Max values (0-100), higher scores mean a worse outcome

Time frame
From date of surgery, assessed up to 90 days
3

Overall Survival

Overall survival analysis will determine whether bioelectrical impedance analysis is a prognostic factor in advanced gastric cancer patients

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
4

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

Time frame
From date of inclusion through study completion - an average of 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Lublin

Lead sponsor

Erasmus Medical Center

Collaborator

Ohio State University

Collaborator

Poznan University of Medical Sciences

Collaborator

Jagiellonian University

Collaborator

Source ClinicalTrials.gov
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