A 66 Patient Multi-Institution Phase IV Post-Authorization Surveillance of ProThelial™ (High Potency Polymerized Cross-linked Sucralfate) -Single Agent Efficacy for the Prevention and Rapid Reversal of Chemo-radiation Induced Oral, Esophageal and Intestinal Mucositis.

ABSTRACT

Background: Standard potency sucralfate is not recommended by most clinical guidelines for prevention or treatment of oral and intestinal mucositis. However, its polymerized cross-linked (thereby high potency) formulation (HPPCLS) was cleared by the FDA for management of oral mucositis and has been associated with complete prevention and rapid reversal of oral, esophageal and intestinal mucositis. Statistically significant high quality evidence from a 66 patient multi-institution phase IV non-controlled observation study is reported here. Patients and Methods: In February 2014, as part of the Phase IV post-approval surveillance of HPPCLS, a non-interventional mucositis registry was established. The primary aim of the registry was the surveillance of patients’ tolerance of HPPCLS. A secondary aim was the observation of the prescribing pattern of oncologists using HPPCLS to manage chemo-radiation induced mucositis. Inclusion Criteria Any cancer treatment patient who developed or was anticipated to develop oral mucositis and was prescribed HPPCLS. Exclusion Criteria Allergies or prior adverse reactions to sucralfate. Conduct of Study Patients identified by oncology clinical staff with mucositis or anticipated to develop mucositis, were prescribed a 75 ml single week-supply of HPPCLS as needed. Results: Thirty-nine oncologists from 32 institutions prescribed HPPCLS to 66 patients. No adverse reactions were reported. Five patients were lost to follow-up and 61 patients reported outcomes. Eight patients experienced successful prevention of mucositis averting placement of gastrostomy tube and the remaining 53 patients with WHO-Grade 1-3 mucositis involving the mouth, esophagus, small bowel & colon experienced reversal in 2-3 days. Though cleared for oral use only, 48 of 61 patients were instructed by oncologists to swallow HPPCLS following swish-and-gargle. Statistical Analysis: Quantitative Glasziou rate-ratio treatment effect beyond 10 (37-82 for HPPCLS) supported efficacy (p≤0.05). Conclusion: HPPCLS paste may offer oncologists a single-agent approach to manage chemo-radiation induced mucositis. To wit a protocol is offered for practical use.