Pancreatic Ductal Adenocarcinoma (PDAC)HEXCARE-PDACNCT07870421
A Study Looking at Whether a Nutritional Composition Can Help People With Pancreatic Cancer Stay Stronger and Better Tolerate Chemotherapy
A study testing A novel cancer-specific high energy high protein medical nutrition solution and A commercially available isocaloric isonitrogenous medical nutritional solution. in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Nutricia Research.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- A novel cancer-specific high energy high protein medical nutrition solution and A commercially available isocaloric isonitrogenous medical nutritional solution.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- Patients with metastatic PDAC (i.e. confirmed distant metastases or otherwise confirmed by local practice)
- Patients who received prior treatment for PDAC
- Life expectancy < 3 months
- 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
- 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
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- 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
- 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
- Severe hypercalcemia, i.e. total calcium level corrected for albumin >14.0mg/dL (>3.5mmol/L)
- Known allergy or intolerance to any of the ingredients of the study products
- Known pregnancy or lactation
- Current alcohol or drug abuse in the opinion of the Investigator
- 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
- Participation in any other studies involving investigational or marketed products within 14 days prior to screening and/or during the intervention period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Danone Global Research & Innovation Center B.V Danone Global Research & Innovation Center B.V contact
About this study
Official title: A Randomized Controlled Study on the Impact of a Specialized Oral Nutritional Supplement on Muscle Mass and Chemotherapy Tolerance in Pancreatic Cancer Patients
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
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- A novel cancer-specific high energy high protein medical nutrition solution, A commercially available isocaloric isonitrogenous medical nutritional solution.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A novel cancer-specific high energy high protein medical nutrition solutionDietary supplement
Dietary Supplement
A commercially available isocaloric isonitrogenous medical nutritional solution.Dietary supplement
Dietary Supplement
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | The test product is a food for special medical purposes (FSMP), it is a novel cancer-specific high energy high protein medical nutrition solution. Receives: Dietary Supplement: A novel cancer-specific high energy high protein medical nutrition solution |
| Control Product | Experimental | The control product is a commercially available isocaloric isonitrogenous medical nutritional solution. Receives: Dietary Supplement: A commercially available isocaloric isonitrogenous medical nutritional solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Index
The primary outcome parameter is the difference between test and control group in the mean change from baseline to the end of neoadjuvant chemotherapy in skeletal muscle mass, expressed as skeletal muscle index (SMI) [cm2/m2] as measured with a CT scan on the third lumbar vertebra (L3) level as skeletal muscle area (SMA) [cm2] corrected for height [m].
Measured: From enrollment to the end of intervention at 12 weeks, max product intake up to 28 weeks
Secondary outcomes (1)
Cumulative Relative Dose Intensity
The key secondary outcome parameter is the difference between test and control group in the mean Cumulative Relative Dose Intensity (cRDI) of FOLFIRINOX or mFOLFIRINOX assessed at the end of neoadjuvant chemotherapy [%].
Measured: From enrollment to the end of intervention at 12 weeks, max study product intake up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870421
- Sponsor's protocol ID
- 23REX0061263
- Acronym
- HEXCARE-PDAC
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Impact of a Specialized Oral Nutritional Supplement on Muscle Mass and Chemotherapy Tolerance in Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT07870421
- Acronym / sponsor ID
- HEXCARE-PDAC / 23REX0061263
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Dietary Supplement: A novel cancer-specific high energy high protein medical nutrition solutionThe test product is a food for special medical purposes (FSMP), it is a novel cancer-specific high energy high protein medical nutrition solution. |
| Control Product | Experimental | Dietary Supplement: A commercially available isocaloric isonitrogenous medical nutritional solution.The control product is a commercially available isocaloric isonitrogenous medical nutritional solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Patients with metastatic PDAC (i.e. confirmed distant metastases or otherwise confirmed by local practice)
- Patients who received prior treatment for PDAC
- Life expectancy < 3 months
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A novel cancer-specific high energy high protein medical nutrition solutionDietary Supplement | Dietary supplement | Test product |
| A commercially available isocaloric isonitrogenous medical nutritional solution.Dietary Supplement | Dietary supplement | Control Product |
Primary outcome
Skeletal Muscle Index
Time frame: From enrollment to the end of intervention at 12 weeks, max product intake up to 28 weeks
The primary outcome parameter is the difference between test and control group in the mean change from baseline to the end of neoadjuvant chemotherapy in skeletal muscle mass, expressed as skeletal muscle index (SMI) [cm2/m2] as measured with a CT scan on the third lumbar vertebra (L3) level as skeletal muscle area (SMA) [cm2] corrected for height [m].
1 secondary outcome
Cumulative Relative Dose Intensity
Time frame: From enrollment to the end of intervention at 12 weeks, max study product intake up to 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danone Global Research & Innovation Center B.V Danone Global Research & Innovation Center B.V contact
Questions about this trial
What is this clinical trial studying?
A study testing A novel cancer-specific high energy high protein medical nutrition solution and A commercially available isocaloric isonitrogenous medical nutritional solution. in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Nutricia Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danone Global Research & Innovation Center B.V Danone Global Research & Innovation Center B.V (+31 30 2095 000, register.clinicalresearchnutricia@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Index (time frame: From enrollment to the end of intervention at 12 weeks, max product intake up to 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.