Randomized Phase II Trial of Two Different Nutritional Approaches for Patients Receiving Treatment for Their Advanced Pancreatic Cancer

Study Identifier:
TD2-PDAC-KETO-001
CT.gov Identifier:
NCT04631445
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Study Complete

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Study Summary

To evaluate the effects of the ketogenic diet in patients with metastatic pancreatic cancer while receiving chemotherapy.

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.

To compare the changes in serum metabolites and quality of life between the two arms.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Pancreas
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Ketogenic (KD) + Triplet
    • Read More
  • Drug: Intervention:
  • Drug: No Intervention: Non-ketogenic + Triplet
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • Age ≥ 18 years of age; male or female.
    • Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma, not previously treated for their metastatic disease.
    • Capable of providing informed consent and complying with trial procedures.
    • Karnofsky Performance Status (KPS) of ≥ 70%.
    • Life expectancy ≥ 12 weeks.
    • Measurable tumor lesions according to RECIST 1.1 criteria.
    • Patient has acceptable coagulation status as indicated by an INR ≤1.5 times institutional upper limit of normal (ULN). Patients on anticoagulation can be included at the discretion of the investigator.
    • Patients must have 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.
    • Patient must have a Smartphone or computer in order to work with Virta
    • 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:
    • 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
    • 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.
    • 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
    • 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).
    • Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
    • 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.
    • 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.
    • Known infection with HIV, hepatitis B, or hepatitis C.
    • Active, uncontrolled bacterial, viral, or fungal infections, requiring systematic therapy.
    • Major surgery within 4 weeks prior to study entry. (Port-a-cath may be inserted during this time period).
    • 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.
    • Any condition in the opinion of the principal investigator that is unstable and could jeopardize the patient's participation in the study.
    • Unwillingness or inability to comply with procedures required in this protocol, including unwillingness to follow a ketogenic diet.
    • Severe malnutrition or body mass index (BMI) < 18.
    • Albumin < 3.0 g/dL.
    • History of Type 1 diabetes.
    • History of diabetic ketoacidosis (DKA).

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Pancreas