Clinical trial · Observational
MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment
MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational Survey | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor Regression Grade
- timeFrame
- Up to 2-4 weeks after the surgery
- description
- determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)
Secondary outcomes (4)
- measure
- Neoadjuvant Chemotherapy Toxicity
- timeFrame
- From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle
- description
- evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0)
- measure
- Postoperative Complications
- timeFrame
- From date of surgery, assessed up to 90 days
- description
- Assessed by the Comprehensive Complication Index (CCI). Min-Max values (0-100), higher scores mean a worse outcome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDPelc Z, Sedlak K, Mlak R, Chawrylak K, Mielniczek K, Lesniewska M, Skorzewska M, Kwietniewska M, Pasnik I, Geca K, van der Sluis P, Banasiewicz T, Pedziwiatr M, Polkowski WP, Pawlik TM, Malecka-Massalska T, Rawicz-Pruszynski K. MalnutritiOn assessment with biOelectrical impedaNce analysis in gastRic cancer patIentS undergoing multimodaltrEatment (MOONRISE)-Study protocol for a single-arm multicenter cross-sectional longitudinal study. PLoS One. 2024 Feb 6;19(2):e0297583. doi: 10.1371/journal.pone.0297583. eCollection 2024. PMID 38319910