NCT07883161Not yet recruiting
Targeted Nutritional Intervention (HMB, Arginine, Glutamine) in Patients With Pancreatic Cancer
Clinical Efficacy and Myokine Profiling Through Targeted Nutritional Intervention (HMB, Arginine, Glutamine) in Patients With Pancreatic Carcinoma: A Stratified Randomized Pilot Trial
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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: * 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 7 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Pancreatic cancer
- NCT number
- NCT07883161
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 1 Dec 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regular use of dietary supplements containing beta-hydroxy-beta-methylbutyrate (HMB), L-glutamine, or L-arginine within 30 days prior to study enrollment
Other illness
- Presence of distant metastatic disease
- Active intestinal obstruction, sub-occlusion, or severe gastrointestinal disorder preventing oral feeding
- Known hypersensitivity or allergy to any component of the study nutritional supplement (Abound: HMB, L-Arginine, L-Glutamine)
Lab values
- Severe renal impairment (creatinine clearance \< 30 mL/min) or decompensated liver disease (Child-Pugh class C, unrelated to PDAC)
Other
- Exclusive Total Parenteral Nutrition (TPN)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Nutrition Unit Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.