Ketogenic Diet for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pancreatic CancerKetogenic Diet - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 36 months

36 months
Cancer Biomarkers
Cancer Biomarkers returning to normal
Change in BMI
Compare insulin levels
Progression-free survival per RECIST 1.1
To compare changes in serum metabolites
To compare quality of life between arms via the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire QLC-C30 (EORTC QLQ-C30) assessment.
To compare the average HbgA1c level
To compare the disease control rate using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1).
To compare the number of responses by RECIST 1.1

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Non-ketogenic + Triplet
1 of 2
Ketogenic (KD) + Triplet
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Ketogenic Diet · No Placebo Group · N/A

Ketogenic (KD) + Triplet
Other
Experimental Group · 1 Intervention: Ketogenic Diet · Intervention Types: Other
Non-ketogenic + TripletNoIntervention Group · 1 Intervention: Non-ketogenic + Triplet · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

Translational Genomics Research InstituteOTHER
34 Previous Clinical Trials
107,954 Total Patients Enrolled
Translational Drug DevelopmentLead Sponsor
17 Previous Clinical Trials
916 Total Patients Enrolled
Brittany Porter, MPHStudy DirectorTranslational Drug Development
Vicki L Bauernschub, BSN RNStudy DirectorTranslational Drug Development

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.
You have metastatic pancreatic ductal adenocarcinoma.
You are eligible for this study if you have a life expectancy ≥ 12 weeks.
Tumor lesions should be measurable according to RECIST 1.1 criteria.
Platelet concentration ≥100,000/mm3 with no platelet transfusions within 7 days prior to laboratory sample.