Unprecedented Simultaneous and Rapid Reversal of Oral and Alimentary Mucositis using Polymerized Cross Linked Sucralfate: Two Case Reports

Ricky Wayne McCullough ¹· ², MD, MSc

¹Department of Medicine & Emergency Medicine ,Veterans Administration Medical Center, Teaching Hospital, Warren Alpert Medical School of Brown University, Providence, Rhode Island 02908 USA²Department of Emergency Medicine Roger Williams Medical Center Providence, Rhode Island 02908 USA

*Corresponding author: Ricky W. McCullough MD, MSc at Mueller Medical International Translational Medicine Research Center 1768 Storrs Road, Storrs-Mansfield CT 06268Department of Medicine and Emergency Medicine Providence Veterans Administration Hospital, Brown University Teaching Hospital, 830 Chalkstone Avenue, Providence RI. E-mail: glencopelph@aol.com , Phone: 860-477-0961

Published: December 23, 2014.


The quest to optimize cancer treatments and to extend cancer survival is consistently thwarted by an unavoidable but expected consequence – mucositis of the oral and gastrointestinal tract. Prior to market approval our Translational Medicine Research Center clinically tested polymerized cross-linked sucralfate (PCLS) on a cancer treatment patient who underwent 6 weeks chemo-radiation for squamous cell carcinoma of head and neck (SCCHN).This late-breaking Phase 4 observational experience from our Center discusses the post-approval use of PCLS (ProThelial™) in 2 patients: one with advanced oroesophageal mucositis from radiation and cetuximab for SCCHN and another patient with oral, esophageal, small and large bowel mucositis caused by Folfirinox (5- fluorouracil, folinic acid, irinotecan and oxaliplatin) for inoperable metastatic pancreatic adenocarcinoma.Standard potency sucralfate is not recommended in the mucositis management guidelines of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC\ISOO). This higher potency sucralfate, PCLS, used in these patients exhibited an unprecedented simultaneously and rapid (2-3 day) reversal of oroesophageal mucositis and alimentary mucositis. These results raise the novel proposition of single-agent management of both oral and alimentary mucositis caused by radiation, classic and newer bioengineered oncolytics.  If validated, PCLS should energize discussions regarding mucositis clinical guidelines.The experience of these patients has been accepted for presentation in the upcoming 2014 International Symposium of the MASCC\ISOO.  Distinctions between standard potency sucralfate and PCLS are reviewed and modes of action explanations are offered.

Sucralfate; Mucositis; MASCC\ISOO; Cetuximab; Folinic acid; 5-fluorouracil; Irinotecan; Oxaliplatin.
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Int J Biomed. 2014; 4(4):242-247. © 2014 International Medical Research and Development Corporation. All rights reserved.