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Metastatic Pancreatic Ductal AdenocarcinomaNCT04631445

Study Evaluating the Ketogenic Diet in Patients With Metastatic Pancreatic Cancer

A study testing Ketogenic Diet in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Translational Drug Development at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the effects of the ketogenic diet in patients with metastatic pancreatic cancer while receiving chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ketogenic Diet
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
6 sitesUnited States
Study dates
2 Dec 2020to 1 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • <Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0.
  • 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].

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Nuvance Health-Danbury Hospital

    Danbury, Connecticut, 06810

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Nuvance Health

    Norwalk, Connecticut, 06856

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229

  • Honor Health

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Ketogenic Diet
Keywords
Metastatic Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Ketogenic Diet, Keto Diet
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketogenic DietOther

    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).

Study groups in NCT04631445
Study groupRoleWhat they receive
Ketogenic (KD) + TripletExperimentalKetogenic 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.
Receives: Other: Ketogenic Diet
Non-ketogenic + TripletNo interventionNon-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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 36 months

Secondary outcomes (9)

  1. 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).

    Measured: 36 months

  2. 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)

    Measured: 36 months

  3. Cancer Biomarkers

    Change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9)

    Measured: 36 months

  4. Cancer Biomarkers returning to normal

    Rates of normalization of CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9)

    Measured: 36 months

  5. Change in BMI

    To compare the average weight (kg), using BMI calculation (BMI = weight (kg) / height (m2))

    Measured: 36 months

  6. Compare insulin levels

    To compare average insulin levels

    Measured: 36 months

  7. To compare the average HbgA1c level

    To compare the average HbgA1c levels

    Measured: 36 months

  8. To compare changes in serum metabolites

    To compare changes in serum metabolites

    Measured: 36 months

  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.

    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.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start2 Dec 2020
  3. Primary completion1 Feb 2025
  4. Study completion1 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Ketogenic diet with standard of care chemotherapy versus non-ketogenic diet with standard of care chemotherapy
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04631445
Sponsor's protocol ID
TD2-PDAC-KETO-001
Status last verified
Feb 2025
First submitted
26 Oct 2020
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35425930

Questions about this trial

What is this clinical trial studying?

A study testing Ketogenic Diet in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Translational Drug Development at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival per RECIST 1.1 (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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