Dr. Joseph Cullen: Clinical Trial Breakthroughs with High-Dose Vitamin C
Is high-dose vitamin C the game-changer in cancer treatment that it's touted to be? Get the latest insights straight from the forefront of clinical research with the leading expert in the field. In this episode, we sit down with Dr. Joseph Cullen, a distinguished Professor of Surgery at the University of Iowa Carver College of Medicine. Dr. Cullen's groundbreaking clinical investigations center on the integration of high-dose vitamin C, also referred to as ascorbate or intravenous vitamin C (IVC), alongside conventional cancer therapies.
Drawing from his extensive experience, Dr. Cullen shared insights from several phase 1 and phase 2 clinical trials he has conducted. Notably, he discussed the groundbreaking results from the first-ever randomized IVC clinical trial which was conducted amongst pancreatic cancer patients. The trial's success was so remarkable that it was halted early, as it was deemed unethical not to offer IVC to all patients alongside standard care medications. These compelling findings have been submitted for publication and we are awaiting its release.
During our conversation, Dr. Cullen also shed light on similar clinical trials being conducted by him and his colleagues at the University of Iowa, targeting glioblastoma, non-small cell lung, and rectal cancers. These trials signify the growing recognition of IVC's potential as an adjunctive therapy in cancer treatment.
Delving into the science behind the efficacy of IVC, Dr. Cullen explained its mechanism of action and why it holds such promise in cancer therapy. His laboratory's research focuses on pharmacological ascorbate (P-AscH-, high dose, intravenous vitamin C) as an adjuvant to standard treatments, particularly for pancreatic cancer but he also addresses its potential for breast and prostate cancers.
With an impressive track record comprising 162 peer-reviewed papers and 32 book chapters, Dr. Cullen is at the forefront of advancing our understanding of IVC's role in cancer care. As the principal investigator of multiple clinical trials utilizing pharmacological ascorbate, he continues to spearhead innovative approaches to enhance cancer therapy through the manipulation of redox metabolism.
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00:00:00 Intro
00:03:23 Dr. Cullen provides bottom line research results and overview of mechanism of action
00:06:21 Impact of catalase in tumor cells and relationship with hypoxia
00:09:00 Genesis of the research; and Phase 1 & 2 Pancreatic clinical trial results
00:10:50 Doses associated with successful clinical trials.
00:12:50 Comparison of IVC clinical trial patients and historical control group and a description of individual patient responses
00:16:52 Phase II randomized IVC trial results overview
00:21:58 Case study of patient/pharmacist using IVC for pancreatic cancer
00:24:51 Overview of results of glioblastoma clinical trial also at University of Iowa
00:26:18 Comparison of IVC side affects versus some experimental chemotherapies
00:28:01 Clinical trials for other cancers (lung, rectal) and benefits of IVC when combined with radiation *Openings in clinical trials
00:30:47 IVC as a chemo sensitizer and radiation sensitizer
00:33:59 Enhancing IVC with fasting
00:35:42 Variances in response to IVC therapy
00:36:55 Clinical significance of results versus statistical significance
00:39:07 IVC safety
00:40:59 Breast cancer and prostate cancer research and information on IVC’s potential ability to repair cardiac damage caused by breast cancer drugs
00:45:29 Do specific gene mutations respond better to IVC (KRAS, BRAF)
00:47:26 How ferritin (iron) and other metals affect response to IVC
00:50:43 Applying a layering strategy to fight cancer
00:51:48 Oral vitamin C for bladder cancer
00:54:09 The future of IVC
00:55:31 Summary of key points
00:57:13 Wrap-up, Important disclaimer information
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O'Leary, Brianne R et al. “Pharmacological Ascorbate Enhances Chemotherapies in Pancreatic Ductal Adenocarcinoma.” Pancreas vol. 51,6 (2022): 684-693. doi:10.1097/MPA.0000000000002086
Chen GY, O'Leary BR, Du J, Carroll RS, Steers GJ, Buettner GR, Cullen JJ. Pharmacologic Ascorbate Radiosensitizes Pancreatic Cancer but Radioprotects Normal Tissue: The Role of Oxidative Stress-Induced Lipid Peroxidation. Antioxidants (Basel). 2024 Mar 18;13(3):361. doi: 10.3390/antiox13030361. PMID: 38539894; PMCID: PMC10967795.
Du J, Cieslak JA 3rd, Welsh JL, Sibenaller ZA, Allen BG, Wagner BA, Kalen AL, Doskey CM, Strother RK, Button AM, Mott SL, Smith B, Tsai S, Mezhir J, Goswami PC, Spitz DR, Buettner GR, Cullen JJ. Pharmacological Ascorbate Radiosensitizes Pancreatic Cancer. Cancer Res. 2015 Aug 15;75(16):3314-26. doi: 10.1158/0008-5472.CAN-14-1707. Epub 2015 Jun 16. PMID: 26081808; PMCID: PMC4537815.
Du, Juan & Pope, Amanda & O'Leary, Brianne & Wagner, Brett & Goswami, Prabhat & Buettner, Garry & Cullen, Joseph. (2022). The role of mitochondria in pharmacological ascorbate-induced toxicity. Scientific Reports. 12. 22521. 10.1038/s41598-022-27185-9.
Wilkes, Justin & Allen, Bryan & Berg, Daniel & Wagner, Brett & Du, Juan & Bodeker, Kellie & Ahmann, Logan & Vollstedt, Sandy & Brown, Heather & Alexander, Matthew & Cullen, Joseph. (2016). Preliminary Results of a Phase I Study of Pharmacological Ascorbate (P-AscH–) with Gemcitabine Chemoradiotherapy in Pancreatic Cancer. Free Radical Biology and Medicine. 100. S132. 10.1016/j.freeradbiomed.2016.10.347.
Du, Juan & Wagner, Brett & Buettner, Garry & Cullen, Joseph. (2015). The Role of Labile Iron in the Toxicity of Pharmacological Ascorbate. Free radical biology & medicine. 84. 10.1016/j.freeradbiomed.2015.03.033.
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For a complete list of clinical trials associated with ascorbate (vitamin C) visit www.clinicaltrials.gov .
— ClinicalTrials.gov ID NCT03541486
— Sponsor Joseph J. Cullen, MD, FACS, University of Iowa
— Recruiting starting 2025
“A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC (XACT-LUNG)”
— ClinicalTrials.gov ID NCT02905591
— Sponsor Joseph J. Cullen, MD, FACS, University of Iowa
“High Dose Ascorbic Acid for Plasma Cell Disorders”
— ClinicalTrials.gov ID NCT03602235
— Sponsor Christopher Strouse, University of Iowa
— ClinicalTrials.gov ID NCT04150042
— Sponsor General Oncology, Inc.
“Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer”
— ClinicalTrials.gov ID NCT05501548
— Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
— ClinicalTrials.gov ID NCT03418038
— Sponsor Mayo Clinic
— ClinicalTrials.gov ID NCT06336902
— Sponsor University of Southern California
— Recruiting starting 2024
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