This study will evaluate the effects of the ketogenic diet in patients with metastatic pancreatic cancer while receiving chemotherapy.
A randomized, phase II trial designed to evaluate the progression free survival in patients with metastatic pancreatic cancer on triplet therapy (nab-paclitaxel + gemcitabine + cisplatin) while on ketogenic diet or non-ketogenic diet. This study also aims to compare the changes in serum metabolites and quality of life between the two arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Ketogenic diet (KD) will consist of macros: dietary carbohydrates restricted to \< 30 g/day; daily protein intake will be targeted to 1.5 g/kg/day (targeted to ideal body weight).
Honor Health
Scottsdale, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Nuvance Health-Danbury Hospital
Danbury, Connecticut, United States
Nuvance Health
Norwalk, Connecticut, United States
Progression-free survival per RECIST 1.1
Progression-free survival (PFS) is defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause.
Time frame: 36 months
To compare the number of responses by RECIST 1.1
To compare the number of complete responses/partial responses as defined by CT scan using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least \> 2X ULN).
Time frame: 36 months
To compare the disease control rate using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1).
(Partial Response + Complete Response + Stable Disease for at least 9 weeks)
Time frame: 36 months
Cancer Biomarkers
Change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9)
Time frame: 36 months
Cancer Biomarkers returning to normal
Rates of normalization of CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9)
Time frame: 36 months
Change in BMI
To compare the average weight (kg), using BMI calculation (BMI = weight (kg) / height (m2))
Time frame: 36 months
Compare insulin levels
To compare average insulin levels
Time frame: 36 months
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Tennessee Oncology
Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
To compare the average HbgA1c level
To compare the average HbgA1c levels
Time frame: 36 months
To compare changes in serum metabolites
To compare changes in serum metabolites
Time frame: 36 months
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.
Higher scores in the quality of life on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire QLC-C30 (EORTC QLQ-C30) assessment may show a better outcome.
Time frame: 36 months