PDACNUTRI-MYONCT07883161
Targeted Nutritional Intervention (HMB, Arginine, Glutamine) in Patients With Pancreatic Cancer
A study testing HMB / L-Arginine / L-Glutamine oral nutritional mixture and Standard Dietary Counseling in people with PDAC and Pancreas Adenocarcinoma (MSI-H), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PDAC, Pancreas Adenocarcinoma (MSI-H)
- What is being tested?
- HMB / L-Arginine / L-Glutamine oral nutritional mixture and Standard Dietary Counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC)
- Locally advanced disease stage (non-metastatic)
- Eligibility and scheduled to start first-line systemic chemotherapy (either in neoadjuvant or adjuvant setting)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Estimated life expectancy > 3 months
- Ability to maintain adequate regular oral food intake
- Signed written informed consent to participate in the study and for biological sample storage
Who cannot join
- Presence of distant metastatic disease
- Severe renal impairment (creatinine clearance < 30 mL/min) or decompensated liver disease (Child-Pugh class C, unrelated to PDAC)
- Active intestinal obstruction, sub-occlusion, or severe gastrointestinal disorder preventing oral feeding
- Exclusive Total Parenteral Nutrition (TPN)
- Known hypersensitivity or allergy to any component of the study nutritional supplement (Abound: HMB, L-Arginine, L-Glutamine)
- Regular use of dietary supplements containing beta-hydroxy-beta-methylbutyrate (HMB), L-glutamine, or L-arginine within 30 days prior to study enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Clinical Nutrition Unit
Roma, RM, 00168
Marco Cintoni, MD, PhD, +39 06 3015 4365, marco.cintoni@policlinicogemelli.it
About this study
Official title: Clinical Efficacy and Myokine Profiling Through Targeted Nutritional Intervention (HMB, Arginine, Glutamine) in Patients With Pancreatic Carcinoma: A Stratified Randomized Pilot Trial
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.
Read more
Participants will be randomly assigned to one of two groups:
- Experimental group: receives standard dietary counseling plus an oral nutritional supplement (Abound, containing beta-hydroxy-beta-methylbutyrate, L-arginine, and L-glutamine) twice daily for 60 days, starting 7 to 10 days before the first cycle of chemotherapy.
- Control group: receives standard dietary counseling alone.
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.
Read the detailed description
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:
- L-Glutamine serves as an essential fuel for enterocytes, supporting intestinal tight-junction integrity and gut barrier function.
- L-Arginine supports immune competence and microvascular perfusion.
- HMB (beta-hydroxy-beta-methylbutyrate) inhibits ubiquitin-proteasome proteolytic pathways while activating mTOR signaling to support muscle protein synthesis.
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:
- Stratum A: Neoadjuvant setting
- Stratum B: Adjuvant setting
Within each stratum, patients are randomized 1:1 using permuted block randomization (block size = 4) into:
- Intervention Arm (n = 12): Oral supplementation with Abound (2 sachets/day delivering 14.8 g L-Glutamine, 14.8 g L-Arginine, and 2.6 g HMB daily), initiated 7-10 days prior to cycle 1 of chemotherapy ("pre-habilitation" phase) and continued through day 60 (T60), plus standard dietary counseling.
- Control Arm (n = 12): Standard of care dietary counseling alone.
PRIMARY AND SECONDARY ASSESSMENTS:
- Primary Outcome: Change in Skeletal Muscle Index (SMI, cm²/m²) from baseline (T0) to day 60 (T60), quantified by computed tomography (CT) densitometric analysis at the third lumbar vertebra (L3).
- Body Composition \& Muscle Quality: L3-CT assessment of muscle attenuation (myosteatosis in Hounsfield Units), visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT).
- Functional Performance: Handgrip strength and Short Physical Performance Battery (SPPB).
- Nutritional \& Inflammatory Status: Serial monitoring of prognostic scores (NLR, PLR, PNI, mGPS).
- Patient-Reported Outcomes (PROMs): Quality of life via EORTC QLQ-C30, pancreatic module PAN26, cachexia module CAX24, and appetite Visual Analogue Scale (VAS).
- Translational Multi-Omics: Fecal microbiota profiling by 16S rRNA sequencing (alpha/beta diversity), systemic intestinal permeability (plasma zonulin), and an extended panel of circulating myokines and metabolic mediators (GDF-15, irisin, myostatin, follistatin, IL-15) sampled at T0 and T60.
- Oncology Follow-up: Prospective tracking of Progression-Free Survival (PFS) and Overall Survival (OS) at 6 and 12 months.
- Conditions
- PDAC, Pancreas Adenocarcinoma (MSI-H)
- Being tested
- HMB / L-Arginine / L-Glutamine oral nutritional mixture, Standard Dietary Counseling
- Keywords
- Cancer Cachexia, Sarcopenia, Nutritional Support, HMB (beta-hydroxy-beta-methylbutyrate), Arginine, Glutamine, Myokines, Body Composition, Gut Microbiota
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMB / L-Arginine / L-Glutamine oral nutritional mixtureDietary supplement
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.
Standard Dietary CounselingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutritional Supplement | Experimental | 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). Receives: Dietary Supplement: HMB / L-Arginine / L-Glutamine oral nutritional mixture |
| Standard Dietary Counseling | Active comparator | 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. Receives: Dietary Supplement: HMB / L-Arginine / L-Glutamine oral nutritional mixture; Other: Standard Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (Day 0) and Day 60
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PDACStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, open-label, monocentric pilot trial with a 1:1 allocation ratio between the experimental arm and the control arm. To balance clinical and metabolic differences between surgical pathways, permuted block randomization (block size = 4) is stratified according to treatment setting: Stratum A (Neoadjuvant setting) and Stratum B (Adjuvant setting).
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Cintoni, Md, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Marco Cintoni, MD, PhD, Principal investigator, Clinical Nutrition Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883161
- Sponsor's protocol ID
- 28030
- Acronym
- NUTRI-MYO
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Raoul P, Cintoni M, Coppola A, Alfieri S, Tortora G, Gasbarrini A, Mele MC, Rinninella E. Preoperative low skeletal muscle mass index assessed using L3-CT as a prognostic marker of clinical outcomes in pancreatic cancer patients undergoing surgery: a systematic review and meta-analysis. Int J Surg. 2024 Oct 1;110(10):6126-6134. doi: 10.1097/JS9.0000000000000989.
PubMed 38836800Trestini I, Cintoni M, Rinninella E, Grassi F, Paiella S, Salvia R, Bria E, Pozzo C, Alfieri S, Gasbarrini A, Tortora G, Milella M, Mele MC. Neoadjuvant treatment: A window of opportunity for nutritional prehabilitation in patients with pancreatic ductal adenocarcinoma. World J Gastrointest Surg. 2021 Sep 27;13(9):885-903. doi: 10.4240/wjgs.v13.i9.885.
PubMed 34621468Cintoni M, Grassi F, Palombaro M, Rinninella E, Pulcini G, Di Donato A, Salvatore L, Quero G, Tortora G, Alfieri S, Gasbarrini A, Mele MC. Nutritional Interventions during Chemotherapy for Pancreatic Cancer: A Systematic Review of Prospective Studies. Nutrients. 2023 Feb 1;15(3):727. doi: 10.3390/nu15030727.
PubMed 36771433