Pancreatic CancerWPSNCT04306874
Whipple Protein Study
A study testing Ensure Max Protein in people with Pancreatic Cancer and Malnutrition, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Study investigators aim to assess the effect of providing high-protein nutritional supplementation before and after surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Malnutrition
- What is being tested?
- Ensure Max Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2019to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 undergoing pancreaticoduodenectomy
- Patients aged 18 years and older
- Patients able to provide written informed consent
- Patients able to understand and comply with study guidelines
- Patients able to tolerate oral intake
- Patients who are malnourished or at risk of malnutrition as defined by a score less than 12 on the Mini-Nutritional Assessment
Who cannot join
- Patients with a milk protein allergy
- Patients with a vegan diet
- Patients dependent on artificial enteral feeding
- Patients with end-stage renal disease undergoing dialysis
- Patients who are pregnant
- Patients with ongoing eating disorder or condition precluding oral intake
- Patients who are scheduled for pancreaticoduodenectomy but are unable to receive this surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy
Study investigators aim to assess the effect of providing high-protein nutritional supplementation before and after surgery
Read the detailed description
Pancreaticoduodenectomy (PD) is a complex and morbid operation that is associated with many potential complications. Many people undergoing PD are malnourished due to their underlying medical condition or difficulties eating in the face of abdominal pain or obstruction from pancreatic disease. This study aims to assess the effect of high-protein dietary supplementation in improving perioperative nutrition and decreasing complications. We will randomize PD patients to an experimental arm in which they take a nutritional, high-protein supplement for 2 weeks before and after surgery, or to a control arm, where they will take a standard postoperative diet without supplementation. Outcomes and nutritional parameters will be examined after they complete the supplements.
- Conditions
- Pancreatic Cancer, Malnutrition
- Being tested
- Ensure Max Protein
- Keywords
- pancreaticoduodenectomy, surgery, nutrition, protein
- Medical subject headings
- Pancreatic Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure Max ProteinDietary supplement
Liquid shake with 30 g protein per serving
| Study group | Role | What they receive |
|---|---|---|
| High Protein Supplement | Experimental | 60 g total protein per day, administered via twice daily ensure max protein shakes Receives: Dietary Supplement: Ensure Max Protein |
| Control | No intervention | No intervention on diet; routine dietary practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
All complications within 30 days of surgery
Measured: 30 days
Secondary outcomes (2)
Overall Survival
Overall survival time since surgery
Measured: 6 months
Prealbumin level
Serum prealbumin level (normal 15-36 mg/dL). Lower levels indicate acute malnutrition.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start20 Aug 2019
- Primary completion10 May 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Model description
- Parallel, non-blinded, randomized controlled two-arm trial: supplement vs. placebo
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harish Lavu, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306874
- Sponsor's protocol ID
- 19D.669
- Other IDs
- JT 14375
- Acronym
- WPS
- Status last verified
- May 2025
- First submitted
- 6 Dec 2019
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT04306874
- Acronym / sponsor ID
- WPS / 19D.669
- Conditions
- Pancreatic Cancer, Malnutrition
- Keywords
- pancreaticoduodenectomy, surgery, nutrition, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 13 Mar 2020 (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.
Study investigators aim to assess the effect of providing high-protein nutritional supplementation before and after surgery
Detailed description
Pancreaticoduodenectomy (PD) is a complex and morbid operation that is associated with many potential complications. Many people undergoing PD are malnourished due to their underlying medical condition or difficulties eating in the face of abdominal pain or obstruction from pancreatic disease. This study aims to assess the effect of high-protein dietary supplementation in improving perioperative nutrition and decreasing complications. We will randomize PD patients to an experimental arm in which they take a nutritional, high-protein supplement for 2 weeks before and after surgery, or to a control arm, where they will take a standard postoperative diet without supplementation. Outcomes and nutritional parameters will be examined after they complete the supplements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel, non-blinded, randomized controlled two-arm trial: supplement vs. placebo
| Arm | Type | Receives |
|---|---|---|
| High Protein Supplement | Experimental | Dietary Supplement: Ensure Max Protein60 g total protein per day, administered via twice daily ensure max protein shakes |
| Control | No intervention | –No intervention on diet; routine dietary practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing pancreaticoduodenectomy
- Patients aged 18 years and older
- Patients able to provide written informed consent
- Patients able to understand and comply with study guidelines
- Patients able to tolerate oral intake
Key exclusion criteria (7 listed)
- Patients with a milk protein allergy
- Patients with a vegan diet
- Patients dependent on artificial enteral feeding
- Patients with end-stage renal disease undergoing dialysis
- Patients who are pregnant
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 |
|---|---|---|
| Ensure Max ProteinLiquid shake with 30 g protein per serving | Dietary supplement | High Protein Supplement |
Primary outcome
Complications
Time frame: 30 days
All complications within 30 days of surgery
2 secondary outcomes
Overall Survival
Time frame: 6 months
Prealbumin level
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Harish Lavu, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure Max Protein in people with Pancreatic Cancer and Malnutrition, run by Thomas Jefferson University at 1 site in United States.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 30 days). 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 7 May 2025.