Study Evaluating The Ketogenic Diet In Patients With Metastatic Pancreatic Cancer

Study Overview

Study Evaluating the Ketogenic Diet in Patients with Metastatic Pancreatic Cancer

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.

Metastatic Pancreatic Ductal Adenocarcinoma

OTHER: Ketogenic Diet

TD2-PDAC-KETO-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-10-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-20
First Submitted that Met QC Criteria 2020-11-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-21
First Posted (ACTUAL) 2020-11-17	Results First Posted N/A	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ketogenic (KD) + Triplet 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.	OTHER: Ketogenic Diet 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).
NO_INTERVENTION: Non-ketogenic + Triplet 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Ketogenic (KD) + Triplet

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.

OTHER: Ketogenic Diet

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).

NO_INTERVENTION: Non-ketogenic + Triplet

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.

Primary Outcome Measures	Measure Description	Time Frame
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.	36 months

Secondary Outcome Measures	Measure Description	Time Frame
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).	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)	36 months
Cancer Biomarkers	Change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9)	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)	36 months
Change in BMI	To compare the average weight (kg), using BMI calculation (BMI = weight (kg) / height (m2))	36 months
Compare insulin levels	To compare average insulin levels	36 months
To compare the average HbgA1c level	To compare the average HbgA1c levels	36 months
To compare changes in serum metabolites	To compare changes in serum metabolites	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.	36 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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. 10. Patient must have a Smartphone or computer in order to work with Virta 11. Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:

1. Either commit to true abstinence

from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations following the last dose of IP; and 2. Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence

from heterosexual contact. 12. Male subjects must practice true abstinence

or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following discontinuation from study treatment, even if he has undergone a successful vasectomy.

True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].

Exclusion Criteria:
1. Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of their metastatic pancreatic disease. Prior treatment in the adjuvant setting with chemotherapy and radiation are allowed, provided at least 6 months have elapsed since completion of the last therapy and recurrence and no lingering toxicities are present (this will be first line treatment for metastatic disease). 2. Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit). 3. History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥ 2 years. 4. Uncontrolled intercurrent illness, including but not limited to New York Heart Association Class III or IV, myocardial infarction within the past 6 months, or unstable arrhythmia. 5. Known infection with HIV, hepatitis B, or hepatitis C. 6. Active, uncontrolled bacterial, viral, or fungal infections, requiring systematic therapy. 7. Major surgery within 4 weeks prior to study entry. (Port-a-cath may be inserted during this time period). 8. Any condition in the opinion of the principal investigator that might interfere with the patient's participation in the study or in the evaluation of the study results. 9. Any condition in the opinion of the principal investigator that is unstable and could jeopardize the patient's participation in the study. 10. Unwillingness or inability to comply with procedures required in this protocol, including unwillingness to follow a ketogenic diet. 11. Severe malnutrition or body mass index (BMI) < 18. 12. Albumin < 3.0 g/dL. 13. History of Type 1 diabetes. 14. History of diabetic ketoacidosis (DKA).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Translational Genomics Research Institute

Investigators

STUDY_DIRECTOR: Steve Norton, MBA PhD, Translational Drug Development

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Yang L, TeSlaa T, Ng S, Nofal M, Wang L, Lan T, Zeng X, Cowan A, McBride M, Lu W, Davidson S, Liang G, Oh TG, Downes M, Evans R, Von Hoff D, Guo JY, Han H, Rabinowitz JD. Ketogenic diet and chemotherapy combine to disrupt pancreatic cancer metabolism and growth. Med. 2022 Feb 11;3(2):119-136. doi: 10.1016/j.medj.2021.12.008.

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Resources

Patients

Caregivers

Clinical Trial Record