What side effects are associated with this type of intervention?

The most common treatments for pancreatic cancer, such as gemcitabine and nab-paclitaxel, are associated with several side effects. These include fatigue, nausea, vomiting, diarrhea, loss of appetite, and myelosuppression, which can lead to anemia, increased risk of infection, and bleeding issues. Peripheral neuropathy, characterized by numbness and tingling in the extremities, is also a notable side effect, particularly with nab-paclitaxel. Dietary management approaches, such as amino acid restriction, are still under study, and their side effects are not well-documented, but they may include nutritional deficiencies and related symptoms.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including the combination of gemcitabine and nab-paclitaxel, which is commonly used for advanced or metastatic pancreatic adenocarcinoma. Other notable FDA-approved treatments include FOLFIRINOX (a regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin) and nanoliposomal irinotecan with fluorouracil and folinic acid for patients who have previously been treated with gemcitabine-based therapy. These treatments aim to improve survival and manage symptoms in patients with advanced pancreatic cancer.

What other types of research exist?

Promising alternatives to specially designed medical food for pancreatic cancer patients include methionine restriction diets, perioperative nutrition support, and immunonutrition. These strategies have shown potential in improving outcomes and tolerability in cancer patients.

← Back to Search

Medical Food

Medical Food for Pancreatic Cancer

N/A

Recruiting

Led By Andrew Hendifar, MD

Research Sponsored by Faeth Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status of ≤ 1

Measurable disease as determined by RECIST 1.1 (at least one measurable lesion must not have been irradiated in the past)

Must not have

Major surgery or significant traumatic injury within 14 days of planned start of NEAAR medical food or the anticipation of the need for a major surgical procedure during the study

Known hypersensitivity, allergy, or religious restrictions regarding pork or pork-derived products; or known allergy to any of the major food allergens as defined by U.S. law (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame); or known allergy or hypersensitivity to , gemcitabine or nab-paclitaxel, PERT products (e.g., Pancreaze), or formulary excipients in these products (refer to the FDA-approved package insert)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (average of 6 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special diet that limits certain protein building blocks to help manage severe pancreatic cancer. It targets patients whose cancer cannot be surgically removed and who may not respond well to standard treatments. The diet aims to slow down or stop cancer growth by depriving it of essential nutrients.

Who is the study for?

Adults with advanced or metastatic pancreatic adenocarcinoma who are starting standard chemotherapy (gemcitabine and nab-paclitaxel) can join. They must have measurable disease, good performance status, adequate organ function, and provide tissue samples. Excluded are those with severe weight issues, certain heart diseases or major surgeries recently, dietary restrictions on meat products, other cancer treatments within 6 months, brain metastasis or allergies to study drugs.

What is being tested?

The trial is testing a medical food designed for pancreatic cancer patients that restricts specific amino acids. Participants will consume this while receiving their first-line chemotherapy treatment. The goal is to assess tolerability and impact on cancer markers.

What are the potential side effects?

Potential side effects aren't specified for the NEAAR Medical Food but may include digestive discomfort due to diet changes. Standard chemo side effects like fatigue, nausea, hair loss and increased infection risk could occur from gemcitabine and nab-paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

I have at least one cancer spot that can be measured and hasn't been treated with radiation.

Select...

I can provide recent biopsy samples of my pancreatic cancer for the study.

Select...

I am 18 years old or older.

Select...

My pancreatic cancer cannot be removed by surgery and has spread.

Select...

My diagnosis is pancreatic cancer, confirmed by a lab test.

Select...

I am eligible for treatment with gemcitabine and nab-paclitaxel.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't had major surgery or serious injury in the last 14 days and don't expect to need major surgery during the study.

Select...

I am allergic to specific foods, medications, or have dietary restrictions related to pork.

Select...

I have cancer that has spread to my brain.

Select...

I do not have serious heart issues or major organ failure.

Select...

I have been diagnosed with an eating disorder or a specific digestive condition.

Select...

I have had treatment for pancreatic cancer within the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (average of 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (average of 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (average of 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Demonstrate tolerability of the NEAAR medical food.

Secondary study objectives

Changes in biomarkers

Overall response rates

Progression-free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nonessential Amino Acid Restriction (NEAAR) Medical FoodExperimental Treatment1 Intervention

This is a single arm study in which all subjects will receive NEAAR medical food.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include chemotherapy, targeted therapy, and dietary management. Chemotherapy, such as gemcitabine and nab-paclitaxel, works by killing rapidly dividing cancer cells, which can help shrink tumors and slow disease progression. Targeted therapies, like PARP inhibitors for patients with BRCA mutations, specifically attack cancer cells with certain genetic abnormalities, sparing normal cells and reducing side effects. Dietary management, including specially designed medical foods that restrict specific amino acids, aims to starve cancer cells of the nutrients they need to grow, potentially slowing tumor growth and improving patient outcomes. This approach is particularly relevant for pancreatic cancer patients as it offers a non-toxic adjunct to traditional treatments, potentially enhancing their effectiveness and improving quality of life.