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

ConditionPancreatic Ductal Adenocarcinoma (PDAC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNutricia Research

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • A novel cancer-specific high energy high protein medical nutrition solution

    Dietary supplement

    Dietary Supplement

  • A commercially available isocaloric isonitrogenous medical nutritional solution.

    Dietary supplement

    Dietary Supplement

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: Test productExperimental treatment 1 intervention
Group B: Control ProductExperimental treatment 1 intervention

Trial outcomes

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 \[m\].

Time frame
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 \[%\].

Time frame
From enrollment to the end of intervention at 12 weeks, max study product intake up to 28 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nutricia Research

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: