NCT07870421Not yet recruiting
A Study Looking at Whether a Nutritional Composition Can Help People With Pancreatic Cancer Stay Stronger and Better Tolerate Chemotherapy
A Randomized Controlled Study on the Impact of a Specialized Oral Nutritional Supplement on Muscle Mass and Chemotherapy Tolerance in Pancreatic Cancer Patients
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
The HEXCARE-PDAC study is a Phase III, randomized, double-blind, controlled, multicenter trial evaluating the effectiveness of a cancer-specific oral nutritional supplement in preserving skeletal muscle mass and improving chemotherapy tolerance in adults with non-metastatic pancreatic ductal adenocarcinoma (PDAC) receiving neoadjuvant FOLFIRINOX-based chemotherapy. The study aims to determine whether targeted nutritional intervention can mitigate cancer-associated muscle loss and improve treatment delivery and clinical outcomes in patients with PDAC
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 216 (estimated)
- First submitted
- 6 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Sept 2029
- Lead sponsor
- Nutricia Research
- Diseases
- Pancreatic cancer
- NCT number
- NCT07870421
What you commit to
- Study type: Interventional
- Planned participants: 216
- From 1 Nov 2026 to the primary completion date, 1 Sept 2029
- No sites listed in no 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
- Patients who received prior treatment for PDAC
- Current alcohol or drug abuse in the opinion of the Investigator
- Participation in any other studies involving investigational or marketed products within 14 days prior to screening and/or during the intervention period
Other illness
- Clinically significant dysphagia, gastrointestinal obstruction or any other condition preventing adequate oral intake to reasonably comply with the protocol recommendation of taking 2 servings of study product per day in the opinion of the Investigator
- Pancreatic insufficiency uncontrolled by enzyme therapy or uncontrolled metabolic conditions such as diabetes mellitus or phenylketonuria, that may compromise the patient's safe participation in the study, in the opinion of the Investigator
- Known allergy or intolerance to any of the ingredients of the study products
Lab values
- Presence of an ileostomy or ileal pouch. Participants with an ileostomy at or near the terminal ileum may be enrolled if, in the opinion of the Investigator, the ileostomy does not affect the absorption of nutrients other than sodium, potassium, and water
- Severe renal dysfunction (estimated Glomerular Filtration Rate (eGFR) \<29 mL/min/1.73m2 or albumin: creatinine (ACR)\>30) or other clinically significant renal dysfunction in the opinion of the Investigator
- Severe hypercalcemia, i.e. total calcium level corrected for albumin \>14.0mg/dL (\>3.5mmol/L)
Other
- Patients with metastatic PDAC (i.e. confirmed distant metastases or otherwise confirmed by local practice)
- Life expectancy \< 3 months
- Hepatic encephalopathy regardless of etiology, reflecting clinically significant hepatic dysfunction that may interfere with metabolic stability, cognition, or safe participation in the study in the opinion of the Investigator
- Known pregnancy or lactation
- Participant not capable of understanding or not willing to adhere to the study procedures and/or other protocol requirements in the opinion of the Investigator
Who the study is looking for
- Patients with pancreatic ductal adenocarcinoma (PDAC) who are scheduled to be treated with (modified) FOLFIRINOX\* chemotherapy (\* or NALIRIFOX if that becomes the standard of care during the study per recognized (inter)national guidelines) as first therapy after initial diagnosis of PDAC
- ECOG performance score 0 or 1
- Age 18 years or above
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.