Study Evaluating the Ketogenic Diet in Patients With Metastatic Pancreatic Cancer

NCT04631445 | Completed

• 1 other identifier: TD2-PDAC-KETO-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

Metastatic Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Ketogenic Diet; Keto Diet

Outcome Measures

Primary Outcomes (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.

  36 months

Secondary Outcomes (9)

• To compare the number of responses by RECIST 1.1

  36 months

• To compare the disease control rate using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1).

  36 months

• Cancer Biomarkers

  36 months

• Cancer Biomarkers returning to normal

  36 months

• Change in BMI

  36 months

Study Arms (2)

Ketogenic (KD) + Triplet

EXPERIMENTAL

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

Non-ketogenic + Triplet

NO INTERVENTION

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.

Interventions

Ketogenic Diet OTHER

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).

Ketogenic (KD) + Triplet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \<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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Translational Drug Development: lead
• Translational Genomics Research Institute: collaborator

Study Sites (6)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Nuvance Health-Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Nuvance Health

Norwalk, Connecticut, 06856, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 35425930 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Steve Norton, MBA PhD

  Translational Drug Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Ketogenic diet with standard of care chemotherapy versus non-ketogenic diet with standard of care chemotherapy

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 17, 2020
• Study Start: December 2, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)