Ketogenic Diet for Pancreatic Cancer

No longer recruiting at 6 trial locations

Overseen By Khara Stemley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Translational Drug Development

Disqualifiers: CNS metastasis, HIV, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a ketogenic diet (high fat, low carb) affects individuals with metastatic pancreatic cancer undergoing chemotherapy. Participants will either follow the diet with their treatment or maintain their usual diet. The goal is to determine if the ketogenic diet can enhance chemotherapy's effectiveness. Suitable candidates for this trial have metastatic pancreatic cancer and have not yet received treatment. As an unphased trial, this study provides a unique opportunity to explore a potentially beneficial dietary approach alongside standard treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a ketogenic diet, which is very low in carbohydrates, might help stop cancer cells from obtaining the energy they need to grow. Studies have found no difference in pancreatic cancer rates between those on a ketogenic diet and those who are not, suggesting the diet does not increase cancer risk.

However, concerns exist. While ketogenic diets can shrink tumors by depriving them of glucose (a type of sugar they need), they might also raise the risk of cachexia, a harmful loss of body weight and muscle. Patients should consider this carefully.

Overall, the ketogenic diet has improved outcomes for some cancer patients compared to non-ketogenic diets. As with any treatment, weighing the benefits against potential risks is crucial. Patients should always consult a healthcare provider before making major dietary changes, especially when dealing with cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a ketogenic diet for pancreatic cancer because it represents a novel approach to treatment. Unlike traditional chemotherapy, which typically relies solely on drugs like nab-paclitaxel, cisplatin, and gemcitabine, this approach combines these drugs with a high-fat, low-carbohydrate diet. This dietary shift may help starve cancer cells of glucose, their primary energy source, potentially making them more vulnerable to chemotherapy. Additionally, this method could enhance the effectiveness of standard drugs, offering hope for improved outcomes in a notoriously difficult-to-treat cancer.

What evidence suggests that the ketogenic diet might be an effective treatment for pancreatic cancer?

This trial will compare a ketogenic diet with a non-ketogenic diet, both combined with chemotherapy, for treating pancreatic cancer. Research has shown that a ketogenic diet, low in carbohydrates, might aid in treating pancreatic cancer. Studies have found that this diet can disrupt a process cancer cells need for growth. When combined with chemotherapy, the ketogenic diet alters how pancreatic cancer cells use energy, reducing their ability to utilize insulin and sugar. This makes the cancer cells more receptive to treatment. Additionally, a review of several studies found that the ketogenic diet can lower blood sugar and insulin levels, potentially improving cancer outcomes. ^{1 3 4 6 7}

Who Is on the Research Team?

Steve Norton, MBA PhD

Principal Investigator

Translational Drug Development

Are You a Good Fit for This Trial?

This trial is for adults with metastatic pancreatic ductal adenocarcinoma who haven't been treated for their advanced disease. They must be able to perform daily activities (KPS ≥ 70%), have a life expectancy of at least 12 weeks, and measurable tumor lesions. Participants need a smartphone or computer, acceptable blood counts and organ function, and agree to use contraception if necessary. Excluded are those with severe malnutrition, certain heart conditions, recent major surgery, uncontrolled illnesses or infections.

Inclusion Criteria

Your tumors can be measured using specific guidelines called RECIST 1.1.

I do not have severe numbness or pain in my hands or feet.

You are expected to live for at least 12 more weeks.

Exclusion Criteria

I do not have any severe illnesses like serious heart conditions.

I have had diabetic ketoacidosis in the past.

I do not have any ongoing serious infections needing treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a ketogenic or non-ketogenic diet along with triplet chemotherapy (nab-paclitaxel, cisplatin, gemcitabine) administered intravenously on Days 1 and 8 every 21 days

36 months

Visits every 21 days for chemotherapy administration

Follow-up

Participants are monitored for progression-free survival, changes in serum metabolites, quality of life, and other secondary outcomes

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Ketogenic Diet

Trial Overview The study tests the ketogenic diet's effects on patients with advanced pancreatic cancer while they undergo chemotherapy. The goal is to see how this high-fat, low-carbohydrate diet might influence cancer treatment outcomes.

How Is the Trial Designed?

Group I: Ketogenic (KD) + Triplet Experimental Treatment 1 Intervention

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.

Group II: Non-ketogenic + Triplet Active Control 1 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.

Who Is Running the Clinical Trial?

Translational Drug Development

Lead Sponsor

Trials

19

Recruited

1,000+

Translational Genomics Research Institute

Collaborator

Trials

36

Recruited

107,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11597385/

The Impact of a Ketogenic Diet on Late-Stage Pancreatic ... The extreme deprivation of carbohydrates in KDs can potentially block cancer cells from using glycolysis, which most tumor cells rely on [13].

2. cshl.edu cshl.edu/the-latest-weapon-against-cancer-is-a-keto-diet/

The latest weapon against cancer is ... a keto diet? Keto diets shrink pancreatic and colorectal tumors by starving them of the glucose they need to survive. But they also speed up development of a lethal wasting ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666634021004098

Ketogenic diet and chemotherapy combine to disrupt ... We show that ketogenic diet changes pancreatic cancer metabolism and its response to chemotherapy, decreasing insulin and glucose use while increasing use of 3 ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1535921/full

Impact of ketogenic diets on cancer patient outcomes This meta-analysis revealed that the ketogenic diet significantly reduced fat mass, visceral fat, insulin levels, blood glucose, fatigue, and insomnia

5. ucsf.edu ucsf.edu/news/2024/08/428251/ketogenic-diet-could-improve-response-pancreatic-cancer-therapy

A Ketogenic Diet Could Improve the Response to ... A breakthrough study shows how a ketogenic diet alters human metabolism and makes a particular pancreatic cancer drug effective by starving ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39599705/

The Impact of a Ketogenic Diet on Late-Stage Pancreatic ... At the pancreas level, no differences in pancreatic cancer incidence rates were observed among the diet groups. Regarding the liver safety ...

7. aacrjournals.org aacrjournals.org/cancerres/article/84/17_Supplement_2/B012/747528/Abstract-B012-Randomized-phase-II-trial-of-two

Abstract B012: Randomized phase II trial of two different ... Nutritional metabolic interventions may fundamentally change the tumor microenvironment and improve outcomes. A ketogenic diet (KD) (lower ...