An interventional study of HMB / L-Arginine / L-Glutamine oral nutritional mixture and Standard Dietary Counseling in PDAC and Pancreas Adenocarcinoma (MSI-H), sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Supportive care
Pancreatic ductal adenocarcinoma (PDAC) is frequently associated with cancer cachexia, a condition characterized by progressive loss of skeletal muscle mass and strength driven by systemic inflammation. Recent evidence suggests that chemotherapy and tumor-related inflammation disrupt the gut-muscle axis, leading to increased intestinal permeability and bacterial imbalance (dysbiosis), which further worsen muscle loss.
The purpose of this pilot study is to evaluate whether an early, targeted nutritional supplement containing beta-hydroxy-beta-methylbutyrate (HMB), L-arginine, and L-glutamine can preserve or increase skeletal muscle mass in patients with locally advanced pancreatic ductal adenocarcinoma starting systemic chemotherapy.
Participants will be randomly assigned to one of two groups:
The total study participation for each patient is 60 days, during which changes in muscle mass, muscle quality, physical function, quality of life, and blood and stool biomarkers will be evaluated.
RATIONALE AND BACKGROUND:
Pancreatic ductal adenocarcinoma (PDAC) carries a high prevalence of cancer cachexia, affecting up to 80% of patients. Chemotherapy and tumor-derived systemic inflammation compromise the intestinal mucosal barrier ("leaky gut"), promoting dysbiosis and systemic translocation of inflammatory mediators that accelerate muscle proteolysis and blunt anabolic signaling.
The NUTRI-MYO study investigates a multimodal nutritional intervention targeting key nodes of the gut-muscle axis:
STUDY DESIGN AND RANDOMIZATION:
NUTRI-MYO is a prospective, randomized, open-label, monocentric pilot clinical trial enrolling 24 adult patients with locally advanced PDAC scheduled to receive first-line systemic chemotherapy.
To balance clinical, anatomical, and metabolic differences between treatment pathways, patients are stratified into two strata:
Within each stratum, patients are randomized 1:1 using permuted block randomization (block size = 4) into:
PRIMARY AND SECONDARY ASSESSMENTS:
1,240 studies on the registry are indexed under Sarcopenia; 405 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 793 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.
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Exclusion Criteria:
Patients receive standard of care dietary counseling combined with an oral nutritional supplement (Abound) at a dose of 2 sachets per day (providing daily 14.8 g L-Arginine, 14.8 g L-Glutamine, and 2.6 g HMB). Supplementation begins 7 to 10 days before the first cycle of chemotherapy (pre-habilitation phase) and continues daily until Day 60 (T60).
Dietary Supplement: HMB / L-Arginine / L-Glutamine oral nutritional mixture
Patients receive standard of care hospital dietary counseling aimed at optimizing caloric and protein intake, without the administration of the targeted nutritional mixture, for the duration of the 60-day study period.
Dietary Supplement: HMB / L-Arginine / L-Glutamine oral nutritional mixture · Other: Standard Dietary Counseling
Oral administration of Abound, 2 sachets per day dissolved in water, preferably between meals. Total daily intake: 14.8 g L-Glutamine, 14.8 g L-Arginine, and 2.6 g beta-hydroxy-beta-methylbutyrate (HMB). Administered starting 7-10 days before cycle 1 of chemotherapy through day 60.
Standardized individualized dietary counseling provided by clinical dietitians to ensure adequate caloric and protein intake according to clinical guidelines throughout the 60 days of observation.
Change from Baseline in Skeletal Muscle Index (SMI) at 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).
Time frame: Baseline (Day 0) and Day 60
Change from Baseline in Muscle Radiation Attenuation and Adipose Depots at Day 60
Radiologic assessment via abdominal CT scan at the L3 level to quantify myosteatosis measured as Mean Muscle Attenuation in Hounsfield Units (HU).
Time frame: Baseline (Day 0) and Day 60
Change from Baseline in Isometric Handgrip Strength at Day 60
Handgrip strength assessed using a calibrated digital dynamometer, measured in kilograms (kg), recording the average/maximum across dominant-hand trials.
Time frame: Baseline (Day 0) and Day 60
Change from Baseline in Short Physical Performance Battery (SPPB) Total Score at 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.
Time frame: Baseline (Day 0) and Day 60
Change from Baseline in Prognostic Nutritional Index at Day 60
Prognostic Nutritional Index (PNI) will be calculated using albumin and lymphocyte levels
Time frame: Baseline (Day 0) and Day 60
Overall Survival (OS) Rate at 6 and 12 Months
OS: Percentage of participants alive from the date of enrollment to the designated follow-up timepoints.
Time frame: Assessed at 6 and 12 months from enrollment
Progression-Free Survival (PFS) Rate at 6 and 12 Months
PFS: Percentage of participants without objective radiological disease progression (according to standard RECIST criteria) or death from any cause.
Time frame: Assessed at 6 and 12 months from enrollment
Change from Baseline in Patient-Reported Quality of Life (EORTC QLQ-C30) at 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.
Time frame: Baseline (Day 0) and Day 60
Change from Baseline in Disease-Specific Symptoms (EORTC QLQ-PAN26) at 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.
Time frame: Baseline (Day 0) and Day 60
Change from Baseline in Patient-Change from Baseline in Cachexia-Related Quality of Life (EORTC QLQ-CAX24) at 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.
Time frame: Baseline (Day 0) and Day 60
Change from Baseline in Fecal Microbiota Composition and Diversity at 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).
Time frame: Baseline (Day 0) and Day 60
Change from Baseline in Circulating Myokines and Muscle-Metabolic Biomarkers at 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.
Time frame: Baseline (Day 0) and Day 60
Change from Baseline in Plasma Zonulin Levels at Day 60
Quantification of circulating plasma zonulin concentrations (ng/mL) as a surrogate biomarker of systemic gut barrier integrity and intestinal tight junction permeability.
Time frame: Baseline (Day 0) and Day 60
Plan to share: No — Individual participant data will not be publicly shared to protect patient privacy and confidentiality. De-identified data or study-related documents may be made available from the Principal Investigator upon reasonable scientific request and after appropriate institutional approval.
Start is estimated for Dec 2026; primary completion for Sep 2027, 9 months later.
Of 474 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 9 months is below that.
Counting every sponsor, half of 485 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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