Trials Sponsors Conditions Drugs Pricing

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (1)

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 \[m\].
From enrollment to the end of intervention at 12 weeks, max product intake up to 28 weeks

Secondary Outcomes (1)

Cumulative Relative Dose Intensity
From enrollment to the end of intervention at 12 weeks, max study product intake up to 28 weeks

Study Arms (2)

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.

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.

Dietary Supplement: A commercially available isocaloric isonitrogenous medical nutritional solution.

Interventions

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Nutricia Research
Industrylead

Central Study Contacts

Danone Global Research & Innovation Center B.V Danone Global Research & Innovation Center B.V

CONTACT

+31 30 2095 000 register.clinicalresearchnutricia@danone.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Double blind
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 13, 2026

Study Start

November 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

A Study Looking at Whether a Nutritional Composition Can Help People With Pancreatic Cancer Stay Stronger and Better Tolerate Chemotherapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Test product

Control Product

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Test product

Control Product

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record