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Medical Food

NEAAR 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (average of 6 months)
Awards & highlights

Study Summary

This trial is testing a new diet for people with pancreatic cancer who are also receiving two routine cancer drugs. The goal is to see if the diet is tolerable and has positive effects.

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.Check my eligibility
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.See study design
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
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I am fully active or can carry out light work.
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I have at least one cancer spot that can be measured and hasn't been treated with radiation.
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I can provide recent biopsy samples of my pancreatic cancer for the study.
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I am 18 years old or older.
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My pancreatic cancer cannot be removed by surgery and has spread.
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My diagnosis is pancreatic cancer, confirmed by a lab test.
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I am eligible for treatment with gemcitabine and nab-paclitaxel.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Demonstrate tolerability of the NEAAR medical food.
Secondary outcome measures
Changes in biomarkers
Duration of best response
Overall response rates
+1 more

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.

Find a Location

Who is running the clinical trial?

Faeth TherapeuticsLead Sponsor
2 Previous Clinical Trials
68 Total Patients Enrolled
Andrew Hendifar, MDPrincipal InvestigatorCedars-Sinai
4 Previous Clinical Trials
84 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity of this experiment in terms of participants?

"This investigation requires the enrolment of 60 qualified participants. Locations offering this medication include University of Arizona Cancer Center in Tucson, Arizona and Hoag Memorial Hospital Presbyterian in Newport Beach, California."

Answered by AI

Could you provide a count of the locations where this clinical trial is taking place?

"Across the nation, 10 research facilities are recruiting for this trial. These include University of Arizona Cancer Center in Tucson, Hoag Memorial Hospital Presbyterian in Newport Beach and Florida Cancer Specialists in Fort Myers among other sites."

Answered by AI

Is it feasible to currently enroll in this research trial?

"Indeed, the updated information on clinicaltrials.gov suggests that this trial is currently recruiting participants. The recruitment process began December 21st 2021 and was most recently refreshed on September 6th 2022 with a goal of 60 patients across 10 sites."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
xCures - Virtual Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am looking at using a combination of approaches and not rely upon one intervention.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How is the food provided and who pays for it?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer
2021. "Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05078775.
~10 spots leftby Dec 2024
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