Trial · NCT07883161
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in Skeletal Muscle Index (SMI) at Day 60 | Baseline (Day 0) and Day 60 | Skeletal Muscle Index (SMI) is calculated from cross-sectional abdominal computed tomography (CT) images at the third lumbar vertebra (L3) level using densitometric muscle area segmentation normalized for height squared (cm²/m²). The primary outcome measure evaluates the difference in SMI between baseline (T0, prior to intervention initiation) and Day 60 (T60). |
| Secondary | Change from Baseline in Muscle Radiation Attenuation and Adipose Depots at Day 60 | Baseline (Day 0) and Day 60 | Radiologic assessment via abdominal CT scan at the L3 level to quantify myosteatosis measured as Mean Muscle Attenuation in Hounsfield Units (HU). |
| Secondary | Change from Baseline in Isometric Handgrip Strength at Day 60 | Baseline (Day 0) and Day 60 | Handgrip strength assessed using a calibrated digital dynamometer, measured in kilograms (kg), recording the average/maximum across dominant-hand trials. |
| Secondary | Change from Baseline in Short Physical Performance Battery (SPPB) Total Score at Day 60 | Baseline (Day 0) and Day 60 | Physical capacity will be measured via the SPPB composite score combining gait speed, balance testing, and chair-rise test. Total score ranges from 0 to 12 points, with higher scores reflecting better functional status and performance. |
| Secondary | Change from Baseline in Prognostic Nutritional Index at Day 60 | Baseline (Day 0) and Day 60 | Prognostic Nutritional Index (PNI) will be calculated using albumin and lymphocyte levels |
| Secondary | Overall Survival (OS) Rate at 6 and 12 Months | Assessed at 6 and 12 months from enrollment | OS: Percentage of participants alive from the date of enrollment to the designated follow-up timepoints. |
| Secondary | Progression-Free Survival (PFS) Rate at 6 and 12 Months | Assessed at 6 and 12 months from enrollment | PFS: Percentage of participants without objective radiological disease progression (according to standard RECIST criteria) or death from any cause. |
| Secondary | Change from Baseline in Patient-Reported Quality of Life (EORTC QLQ-C30) at Day 60 | Baseline (Day 0) and Day 60 | Multidimensional assessment evaluated through validated instruments: EORTC QLQ-C30 (core oncology questionnaire; scores 0-100). Higher functional scores indicate better function; higher symptom scores indicate worse symptom severity. |
| Secondary | Change from Baseline in Disease-Specific Symptoms (EORTC QLQ-PAN26) at Day 60 | Baseline (Day 0) and Day 60 | Pancreatic cancer-specific symptoms and side effects assessed using the EORTC QLQ-PAN26 module, comprising 26 items covering disease-specific symptoms (e.g., pain, digestive issues, cachexia-related signs). Scores are linearly converted to a 0 to 100 scale, where higher scores represent greater symptom severity/burden. |
| Secondary | Change from Baseline in Patient-Change from Baseline in Cachexia-Related Quality of Life (EORTC QLQ-CAX24) at Day 60 | Baseline (Day 0) and Day 60 | Cancer cachexia-specific symptom burden and psychosocial impact assessed using the EORTC QLQ-CAX24 module, consisting of 24 items evaluating cachexia-related eating difficulties, food worries, and physical decline. Scores are linearly transformed to a 0 to 100 scale, with higher scores reflecting worse cachexia-related symptoms and impact. |
| Other | Change from Baseline in Fecal Microbiota Composition and Diversity at Day 60 | Baseline (Day 0) and Day 60 | Taxonomic and compositional alterations in gut microbiota will be evaluated via 16S rRNA gene sequencing from stool samples, assessing alpha diversity (Shannon and Chao1 indices) and beta diversity (UniFrac distances). |
| Other | Change from Baseline in Circulating Myokines and Muscle-Metabolic Biomarkers at Day 60 | Baseline (Day 0) and Day 60 | Plasma quantification (pg/mL or ng/mL via immunoenzymatic assay/ELISA) of a targeted panel of myokines and cachexia mediators: GDF-15, Irisin, Myostatin, Follistatin, and IL-15. |
| Other | Change from Baseline in Plasma Zonulin Levels at Day 60 | Baseline (Day 0) and Day 60 | Quantification of circulating plasma zonulin concentrations (ng/mL) as a surrogate biomarker of systemic gut barrier integrity and intestinal tight junction permeability. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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