Medical Food for Pancreatic Cancer

No longer recruiting at 9 trial locations

Overseen By Faeth 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special medical food designed to help manage pancreatic cancer that cannot be surgically removed or has spread. The goal is to determine if NEAAR Medical Food (Nonessential Amino Acid Restriction Medical Food), when used with standard cancer drugs gemcitabine and nab-paclitaxel, is tolerable and effective. The trial is open to patients with locally advanced or metastatic pancreatic adenocarcinoma who are eligible for these treatments. Participants should not have had certain prior cancer treatments or specific health conditions that could interfere with the trial. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options that could potentially improve patients' quality of life.

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.

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

Research has shown that NEAAR Medical Food works by limiting certain proteins, potentially helping to control cancer growth. This method differs from traditional treatments. The research on this medical food remains in the early stages, so solid information about its safety for people is limited.

As the study is just beginning, researchers are still learning about its tolerability. Information on side effects or negative reactions may be scarce. Early studies typically help identify these issues.

Prospective participants should discuss any concerns with the study team to understand the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for pancreatic cancer, such as chemotherapy and radiation, NEAAR Medical Food offers a novel approach by focusing on nutrition. Researchers are excited about this treatment because it involves restricting certain nonessential amino acids, which cancer cells rely on to grow. This dietary strategy potentially starves the cancer cells without the harsh side effects typical of conventional therapies, offering a less toxic and more targeted intervention.

What evidence suggests that NEAAR Medical Food might be an effective treatment for pancreatic cancer?

Research has shown that reducing certain proteins in the diet can slow tumor growth in early cancer studies. In one study with 304 pancreatic cancer patients, 70% maintained or improved their health with a specially designed medical food. This is crucial for staying healthy during treatment. In this trial, all participants will receive the NEAAR Medical Food, which limits specific proteins that cancer cells need, potentially weakening them and enhancing treatment effectiveness. While more human research is needed, early results are promising. ^{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.

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

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?

Group I: Nonessential Amino Acid Restriction (NEAAR) Medical Food Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Faeth Therapeutics

Lead Sponsor

Trials

4

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05078775

Study Details | NCT05078775 | Medical Food for the ... This is a single arm study evaluating the tolerability and markers of pancreatic cancer with a specially designed medical food restricted in specific amino ...

2. withpower.com withpower.com/trial/phase-pancreatic-neoplasms-9-2021-91737

Medical Food for Pancreatic Cancer · Info for Participants In a study of 304 pancreatic cancer patients, 70% maintained or improved their nutritional status during treatment, which is crucial for their overall health.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0304419X23002111

Dietary approaches for exploiting metabolic vulnerabilities ... One early-phase exploratory clinical trial currently explores the effects of Non Essential Amino Acid Restricted medical food (NEAAR) for patients diagnosed ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11657127/

A whole food, plant-based diet reduces amino acid levels ... Limiting the dietary intake of amino acids has been shown to slow tumor growth in pre-clinical models of cancer. We show that consuming a whole ...

5. nature.com nature.com/articles/s12276-020-0375-3

Amino acids in cancer | Experimental & Molecular Medicine Amino acids, nutrients vital to the survival of all cell types, experience reprogrammed metabolism in cancer.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05078775

Study Details | NCT05078775 | Medical Food for the ... This is a single arm study evaluating the tolerability and markers of pancreatic cancer with a specially designed medical food restricted in specific amino ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6487678/

Dietary N-nitroso compounds and risk of pancreatic cancer N-nitroso compounds (NOCs) are among the most potent dietary and pancreatic carcinogens. N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA) are ...

8. letswinpc.org letswinpc.org/research/metastatic-pancreatic-cancer-chemotherapy-diet/

Managing Metastatic Pancreatic Cancer with ... This clinical trial aims to determine if a medical diet that restricts three nonessential amino acids (proline, serine, and glycine) could ...