18 Participants NeededMy employer runs this trial

Structured Lipid Medical Food for Pancreatic Cancer

Recruiting at 1 trial location
EK
Overseen ByEdmond K Appiah, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new structured lipid medical food designed to help people with pancreatic cancer absorb fat more effectively and improve their nutrition. Many individuals with pancreatic cancer struggle to absorb fat due to pancreatic issues, leading to weight loss and stomach troubles. The trial aims to determine if this new food outperforms current treatments. People with pancreatic cancer who experience weight loss and stomach issues might be suitable candidates for this study. Participants will consume the structured lipid food mixed with their meals or drinks for 8 weeks to assess its effectiveness. As an unphased trial, this study provides an opportunity to explore innovative nutritional solutions for pancreatic cancer patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this structured lipid medical food is safe for patients with pancreatic cancer?

Research has shown that Encala, a special type of medical food, helps the body absorb fat more effectively without requiring assistance from the pancreas or bile. This benefit is particularly useful for individuals with pancreatic issues that hinder fat absorption. Updates from Solace Nutrition, the company behind Encala, indicate that it also aids in the absorption of certain fat-based medications, suggesting good tolerance among most users. Although large studies have not yet provided detailed safety information, Encala is designed to safely and effectively address absorption issues.12345

Why are researchers excited about this trial?

Unlike the standard treatments for pancreatic cancer, which often involve chemotherapy and surgery, Encala® is a structured lipid medical food that offers a novel approach. This treatment is different because it focuses on improving nutritional status and fat absorption, which can be challenging for pancreatic cancer patients. By providing a daily dose mixed with food or drinks, Encala® aims to enhance patients' overall well-being and manage gastrointestinal symptoms, potentially improving their quality of life. Researchers are excited about Encala® because it could address nutritional deficiencies in a way that current treatments do not.

What evidence suggests that this structured lipid medical food is effective for pancreatic cancer?

Research has shown that Encala®, a special medical food, can enhance fat absorption without requiring assistance from the pancreas or bile. This is crucial for individuals with pancreatic cancer who often face challenges in absorbing fats. Studies have found that Encala® increases the absorption of nutrients and medications that dissolve in fat, potentially helping to manage symptoms related to poor fat absorption. Tests on patients with pancreatic diseases have demonstrated that Encala® can improve nutrient absorption and possibly enhance quality of life. This trial will evaluate the feasibility, tolerance, safety, and effects of Encala® on fat absorption, gastrointestinal symptoms, and nutritional status in patients with pancreatic cancer, suggesting it could be a beneficial option for those experiencing fat absorption issues due to pancreatic problems.12678

Who Is on the Research Team?

VA

Virginia A Stallings, MD

Principal Investigator

Children's Hospital of Philadelphia

JN

Jefferson N Brownell, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for adults (18+) with pancreatic cancer or pancreatic neuroendocrine tumors who have trouble absorbing fat, are able to eat by mouth or tube for most of their calories, and have a life expectancy of at least 4 months. People who are pregnant, can't eat by mouth, allergic to soy lecithin, or unable to consent cannot join.

Inclusion Criteria

I have a neuroendocrine tumor and recent GI problems like weight loss or diarrhea.
Life expectancy of 4 months or greater
Oral or enteral tube feeding for > 60% daily calories
See 1 more

Exclusion Criteria

Pregnant or lactating
Unable to consume food by mouth (oral intake)
Allergy to soy lecithin product ingredients
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the structured lipid medical food (Encala®) for 8 weeks, consuming 4-5 daily doses mixed with food, beverages, or enteral feeding formulations.

8 weeks
3 visits (in-person) at baseline, 4 weeks, and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in nutritional biomarkers and quality of life.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Structured Lipid Medical Food

Trial Overview

The study is testing a special medical food powder called Encala® (a structured lipid) to see if it helps people with pancreatic cancer better absorb fats and improve nutrition compared to standard care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Encala interventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

Citations

NCT07554560 | Nutrition Intervention for Pancreatic Cancer

Participants in this single-arm study will receive a structured lipid medical food (Encala®) administered daily for 8 weeks. The intervention ...

Examining the dietary contributions of lipids to pancreatic ...

The findings suggest that the intake of nuts and unsaturated fatty acids may be associated with a reduced incidence of PC, whereas increased ...

Solace Nutrition Announces Clinical and Scientific Updates for ...

Encala's structured-lipid technology has demonstrated the ability to enhance oral absorption of lipid-soluble medications, including fenretinide. A novel drug ...

Nutrition Intervention for Pancreatic Cancer

The structured lipid medical food evaluated in this study is designed to improve fat absorption without requiring pancreatic lipase or bile acids ...

(PDF) LPC-rich Nutrition Therapy Increased Gut Absorption ...

Results In those with lower baseline CFA, 3-month LXS treatment improved CFA significantly (8.7%, from 77.4 to 86.0%, P < 0.01), with a ...

Solace Nutrition Announces Clinical and Scientific Updates ...

Encala's structured-lipid technology has demonstrated the ability to enhance oral absorption of lipid-soluble medications, including fenretinide ...

Dietary fat consumption and cancer outcomes: an umbrella ...

Epidemiological studies indicate that both the quantity and quality of dietary fats are important determinants of health outcomes [2]. Excessive intake of SFA ...

Nutrition Intervention for Pancreatic Cancer

The structured lipid medical food evaluated in this study is designed to improve fat absorption without requiring pancreatic lipase or bile ...