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Study Evaluating the Ketogenic Diet in Patients With Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04631445
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : April 24, 2023
Sponsor:
Collaborator:
Translational Genomics Research Institute
Information provided by (Responsible Party):
Translational Drug Development

Study Description
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Brief Summary:
This study will evaluate the effects of the ketogenic diet in patients with metastatic pancreatic cancer while receiving chemotherapy.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Ductal Adenocarcinoma Other: Ketogenic Diet Not Applicable

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Ketogenic diet with standard of care chemotherapy versus non-ketogenic diet with standard of care chemotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Two Different Nutritional Approaches for Patients Receiving Treatment for Their Advanced Pancreatic Cancer
Actual Study Start Date : December 2, 2020
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival per RECIST 1.1 [ Time Frame: 36 months ]
    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.


Secondary Outcome Measures :
  1. To compare the number of responses by RECIST 1.1 [ Time Frame: 36 months ]
    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).

  2. To compare the disease control rate using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). [ Time Frame: 36 months ]
    (Partial Response + Complete Response + Stable Disease for at least 9 weeks)

  3. Cancer Biomarkers [ Time Frame: 36 months ]
    Change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9)

  4. Cancer Biomarkers returning to normal [ Time Frame: 36 months ]
    Rates of normalization of CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9)

  5. Change in BMI [ Time Frame: 36 months ]
    To compare the average weight (kg), using BMI calculation (BMI = weight (kg) / height (m2))

  6. Compare insulin levels [ Time Frame: 36 months ]
    To compare average insulin levels

  7. To compare the average HbgA1c level [ Time Frame: 36 months ]
    To compare the average HbgA1c levels

  8. To compare changes in serum metabolites [ Time Frame: 36 months ]
    To compare changes in serum metabolites

  9. 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. [ Time Frame: 36 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years of age; male or female.
  2. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma, not previously treated for their metastatic disease.
  3. Capable of providing informed consent and complying with trial procedures.
  4. Karnofsky Performance Status (KPS) of ≥ 70%.
  5. Life expectancy ≥ 12 weeks.
  6. Measurable tumor lesions according to RECIST 1.1 criteria.
  7. <Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0.
  8. 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.

  9. 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.
  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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631445


Contacts
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Contact: Katie Gazarik 602.358.8336 kgazarik@td2inc.com
Contact: Brittany Porter, MPH 602.358.8370 bporter@td2inc.com

Locations
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United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Gayle Jameson       gjameson@honorhealth.com   
Principal Investigator: Gayle Jameson, NP         
United States, California
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Walker Brock, RN       walker.brock@hoag.org   
Contact: Rabia Rehman       rabia.rehman@med.usc.edu   
Principal Investigator: Diana Hanna, MD         
United States, Connecticut
Nuvance Health-Danbury Hospital Recruiting
Danbury, Connecticut, United States, 06810
Contact: Sarah Evans, BSN, RN, OCN    203-739-6985    Sarah.Evans@nuvancehealth.org   
Principal Investigator: Richard Frank, MD         
Nuvance Health Recruiting
Norwalk, Connecticut, United States, 06856
Contact: Elaina Vicari       Elaina.Vicari@nuvancehealth.org   
Principal Investigator: Richard Frank, MD         
United States, New Jersey
Atlantic Health System Active, not recruiting
Morristown, New Jersey, United States, 07962
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ask Sarah    844-482-4812      
Principal Investigator: Meredith Sellers Pelster, MD         
United States, Texas
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Contact: Jasmine DeBlanc    210-593-5978    jasmine.deblanc@startsa.com   
Principal Investigator: Drew Rasco, MD         
Baylor Scott and White Withdrawn
Temple, Texas, United States, 76508
Sponsors and Collaborators
Translational Drug Development
Translational Genomics Research Institute
Investigators
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Study Director: Vicki L Bauernschub, BSN RN Translational Drug Development
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Translational Drug Development
ClinicalTrials.gov Identifier: NCT04631445    
Other Study ID Numbers: TD2-PDAC-KETO-001
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: April 24, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Translational Drug Development:
Metastatic Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Ketogenic Diet
Keto Diet
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases