Study Evaluating the Ketogenic Diet in Patients With Metastatic Pancreatic Cancer

Metastatic Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04631445
• Other study ID #: TD2-PDAC-KETO-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: June 2023
• Source: Translational Drug Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: April 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ß -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).

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United States	Nuvance Health-Danbury Hospital	Danbury	Connecticut
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Tennessee Oncology	Nashville	Tennessee
United States	Nuvance Health	Norwalk	Connecticut
United States	South Texas Accelerated Research Therapeutics, LLC	San Antonio	Texas
United States	Honor Health	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Translational Drug Development	Translational Genomics Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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