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Ketogenic Diet for Pancreatic Cancer

N/A
Recruiting
Research Sponsored by Translational Drug Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
<Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0
Normal organ and marrow function as defined below: Absolute neutrophil count ≥1,500/mm3, Platelet concentration ≥100,000/mm3 with no platelet transfusions within 7 days prior to laboratory sample, Hemoglobin ≥ 9.0g/dL (PRBCs may be given to meet this criteria), Hematocrit level ≥ 27%, Total bilirubin within 1.25 x ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed), Serum creatinine < 1.5 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial will study whether the ketogenic diet can help cancer patients with chemotherapy.

Who is the study for?
This trial is for adults with metastatic pancreatic ductal adenocarcinoma who haven't been treated for their advanced disease. They must be able to perform daily activities (KPS ≥ 70%), have a life expectancy of at least 12 weeks, and measurable tumor lesions. Participants need a smartphone or computer, acceptable blood counts and organ function, and agree to use contraception if necessary. Excluded are those with severe malnutrition, certain heart conditions, recent major surgery, uncontrolled illnesses or infections.Check my eligibility
What is being tested?
The study tests the ketogenic diet's effects on patients with advanced pancreatic cancer while they undergo chemotherapy. The goal is to see how this high-fat, low-carbohydrate diet might influence cancer treatment outcomes.See study design
What are the potential side effects?
Potential side effects from following a ketogenic diet may include fatigue, nausea, constipation or diarrhea due to dietary changes. There could also be an increased risk of nutrient deficiencies without careful monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have severe numbness or pain in my hands or feet.
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My blood and organ functions are within normal ranges.
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I can follow the study's rules on birth control and pregnancy testing.
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My pancreatic cancer has spread and hasn't been treated yet.
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I will not have unprotected sex during and for 6 months after the study.
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I am able to care for myself but may not be able to do active work.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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
Progression-free survival per RECIST 1.1
Secondary outcome measures
Cancer Biomarkers
Cancer Biomarkers returning to normal
Change in BMI
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ketogenic (KD) + TripletExperimental Treatment1 Intervention
Ketogenic diet plus nab-paclitaxel 125 mg/m2, cisplatin 25 mg/m2, and gemcitabine 1000 mg/m2 all administered intravenously (IV) on Days 1 and 8 every 21 days.
Group II: Non-ketogenic + TripletActive Control1 Intervention
Non-ketogenic diet plus nab-paclitaxel 125 mg/m2, cisplatin 25 mg/m2, and gemcitabine 1000 mg/m2 all administered intravenously (IV) on Days 1 and 8 every 21 days.

Find a Location

Who is running the clinical trial?

Translational Drug DevelopmentLead Sponsor
18 Previous Clinical Trials
980 Total Patients Enrolled
Translational Genomics Research InstituteOTHER
35 Previous Clinical Trials
106,995 Total Patients Enrolled
Brittany Porter, MPHStudy DirectorTranslational Drug Development

Media Library

Ketogenic Diet Clinical Trial Eligibility Overview. Trial Name: NCT04631445 — N/A
Pancreatic Cancer Research Study Groups: Ketogenic (KD) + Triplet, Non-ketogenic + Triplet
Pancreatic Cancer Clinical Trial 2023: Ketogenic Diet Highlights & Side Effects. Trial Name: NCT04631445 — N/A
Ketogenic Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04631445 — N/A

Frequently Asked Questions

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

In what quantity of healthcare institutions is this experiment being conducted?

"The study is currently calling for patients at 7 sites, with Morristown, Norwalk and Danbury among the locations. To optimize convenience, it's best to select a site that is close by your residence."

Answered by AI

Are there any available spots for new participants in this trial?

"According to the data hosted on clinicaltrials.gov, this study is actively enrolling participants. The trial was initially available for review on December 2nd 2020 and its most recent update occurred June 9th 2022."

Answered by AI

How many participants will the maximum capacity of this research accommodate?

"Affirmative, clinicaltrials.gov confirms that this procedure is actively seeking volunteers since its inception on December 2nd 2020. 40 individuals need to be recruited from 7 different medical sites by June 9th 2022."

Answered by AI
~9 spots leftby Mar 2025