Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

60 Participants Needed

Medical Food for Pancreatic Cancer

Recruiting at 9 trial locations

Overseen ByFaeth Therapeutics

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Faeth Therapeutics

Must be taking: Gemcitabine, Nab-paclitaxel

Disqualifiers: Cerebral metastasis, Other malignancy, Cardiac disease, others

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 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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should be eligible for standard treatment with gemcitabine and nab-paclitaxel, which suggests that these medications may be part of the treatment plan.

How does NEAAR Medical Food differ from other treatments for pancreatic cancer?

NEAAR Medical Food is unique because it focuses on restricting nonessential amino acids, which may influence cancer growth, unlike traditional treatments that often involve chemotherapy or surgery. This dietary approach is novel as it targets the nutritional aspects of cancer management.¹ ² ³ ⁴ ⁵

What data supports the effectiveness of the treatment NEAAR Medical Food for pancreatic cancer?

Research suggests that nutritional interventions, like enteral nutrition and dietary supplements with omega-3 fatty acids, can help improve weight and reduce complications in pancreatic cancer patients. While NEAAR Medical Food is not directly studied, similar nutritional approaches have shown benefits in managing malnutrition and weight loss associated with pancreatic cancer.² ³ ⁶ ⁷ ⁸

Who Is on the Research Team?

Andrew Hendifar, MD

Principal Investigator

Cedars-Sinai

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am fully active or can carry out light work.

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

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

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Exclusion Criteria

I have not had treatment for advanced pancreatic cancer, except as part of initial therapy.

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.

Body mass index (BMI) <18.5 kg/m2 or >40 kg/m2 or serious or refractive cachexia or anorexia that, in the investigator's judgment, prohibits subjects from having energy or appetite sufficient to reliably engage in a strict medical food regimen for an extended time

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NEAAR medical food along with gemcitabine and nab-paclitaxel for pancreatic cancer management

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

NEAAR Medical Food

Trial Overview 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.

How Is the Trial Designed?

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Faeth Therapeutics

Lead Sponsor

Trials

Recruited

170+

Published Research Related to This Trial

In a study of 304 pancreatic cancer patients, 70% maintained or improved their nutritional status during treatment, which is crucial for their overall health.

Improvement in nutritional status, as measured by the Subjective Global Assessment (SGA), was linked to a significantly lower risk of mortality, with patients showing improved SGA having a 1.5 times lower risk of death compared to those with deteriorated SGA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of systematic nutritional assessment and medical nutrition therapy in pancreatic cancer.Vashi, P., Popiel, B., Lammersfeld, C., et al.[2015]

Patients with pancreatic cancer who develop irreversible cachexia have a very short life expectancy of less than 3 months, highlighting the urgent need for early nutritional assessment and intervention.

Nutritional counseling and pancreatic enzyme replacement therapy are essential components of nutritional treatment, helping to alleviate symptoms and improve the nutritional status of patients undergoing various treatments for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Nutritional Status and the Impact of Nutritional Treatment in Patients with Pancreatic Cancer.Mękal, D., Sobocki, J., Badowska-Kozakiewicz, A., et al.[2023]