Atlantic Health to Begin Medical Food Clinical Trials for Pancreatic Cancer

Atlantic Health System Cancer Care is the only cancer program in New Jersey to participate in these nutrition-focused studies

Atlantic Health System Cancer Care in Morristown is enrolling participants in two studies that investigate whether nutritional therapies can increase the benefit of anticancer agents for patients with metastatic pancreatic cancer.

Internationally renowned pancreatic cancer researcher Angela T. Alistar, MD, medical director of GI medical oncology and of the Breakthrough Treatment Center at Atlantic Health System’s Morristown Medical Center, serves as local principal investigator (PI) for the two studies. Atlantic Health System Cancer Care is the only study site in New Jersey for both clinical trials.

“While pancreatic cancer is one of the deadliest malignancies, we are making progress in both understanding it and in developing new potential therapies,” said Dr. Alistar. “I am optimistic that clinical trials are enabling us to speed progress toward cures.”

One active area that is being explored is medical food/nutritional therapy. These therapies have the potential to reprogram cell metabolism in ways that can potentially increase response to specific cancer treatment. We now understand that certain nutrients are vital for tumor metabolism and cancer cell survival. By modulating a patient’s diet, we hope to deplete the nutritional resources for pancreatic cancer cells and improve patient response to cancer treatment, with the ultimate goal of increasing survival for patients with pancreatic cancer.

The pancreas is a key organ that controls the metabolism. Interventions that change the metabolism of pancreatic cancer cells are scientifically sound.

“What we eat matters as proven by emerging science and data in various tumors. In pancreatic cancer this likely matters even more. We have just scratched the surface in the use of nutritional therapies,” said Dr. Alistar. “We hope that these two studies advance our knowledge of how nutrition and diet impact cancer metabolism, to become a new pillar of cancer care to improve patient outcomes.”

The two studies are:

  • Study Evaluating the Ketogenic Diet in Patients With Metastatic Pancreatic Cancer. Participants in this Phase 2 clinical trial will be randomized to receive either a ketogenic diet or non-ketogenic diet. Patients in both arms of the study will also be given standard-of-care agents (nab-paclitaxel, gemcitabine and cisplatin). The study’s primary goal will be to see if addition of the diet to chemotherapy will slow disease progression. Researchers will also compare the changes in chemical compounds in the blood (serum metabolites) of study participants, and will examine potential quality-of-life differences between the two groups. The ketogenic diet is very low in carbohydrates, has a moderate amount of protein and is high in fat. This study is sponsored by Translational Drug Development (TD2), with the collaboration of the Translational Genomics Research. NCT T04631445
  • Medical Food for the Dietary Management of Metastatic Pancreatic Cancer. All participants in this single-arm study will be given standardized, specially designed medical food, which eliminates certain nonessential amino acids (nonessential amino acid restriction—NEAAR). Each week, study participants will receive NEAAR medical food for five consecutive days, followed by two days of their usual diet. All participants will also be given two first-line drug therapies, gemcitabine and nab-paclitaxel. The study will look at whether this diet is tolerable and whether it affects markers of pancreatic cancer activity in patients’ blood, as well as the number of serious adverse events that study subjects may suffer. This study is sponsored by Faeth Therapeutics. NCT05078775

To learn more about criteria for participation in these studies, contact Nancy Ginder, RN, BSN at 973-971-6608 or Miriam Atchley at 973-971-6267.

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