UnknownNot Applicable

ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial

United States180 participantsStarted 2013-01

Plain-language summary

RATIONALE: Polymerized (cross-linked) sucralfate malate paste (ProThelial) may be an effective single therapy approach for the management of chemoradiation mucositis, treating and preventing its occurrence in the oral cavity, esophagus, stomach, small and large intestine. PURPOSE: This observational multi-phase trial is studying how well polymerized (cross-linked) sucralfate malate paste (ProThelial) works to prevent and treat mucositis in adult patients who are to receive or have received chemo/radiation therapy that have caused or is anticipated to cause mucositis in the oral cavity, esophagus, stomach, small or large intestine. The Phase IV study addresses prevention and treatment in the oral cavity. The Phase I study addresses prevention and treatment in the esophagus, stomach, small and large intestine.

Who can participate

Age range18 Years – 95 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years and older * Informed consent * Patients receiving cancer therapy with agents likely to cause mucositis * Patients who have developed mucositis from chemo/and or radiation * Patients to receive these that cause nausea, vomiting * Patients to receive these that cause diarrhea * Patients with Head \& Neck cancer to receive chemo/radiation and G-Tube * Patients to undergo Hematopoietic Stem Cell Transplantation Exclusion Criteria: * Absence of consent * Unable or unwilling to complete the self assessment questionnaire. * Use of any mouthwash out of study * Simultaneous treatment by an agent for prevention/treatment of mucositis * Patients with baseline creatinine level greater than or equal to 3 or any patient with renal insufficiency requiring dialysis * Have known allergies or intolerance to ProThelial or its ingredients (sucralfate)

What they're measuring

Change from Baseline in Oral Mucositis Assessment Score (OMAS) at Day 1, 2,4,7,14,21

Timeframe: Baseline, Day 1, 2, 4, 7, 14, 21

Change from Baseline in Oral Mucositis Assessment Score (OMAS) at Day 1, 2,4,7,14,21

Timeframe: Baseline, Day 1, 2,4,7,14,21

Trial details

NCT IDNCT02016807

SponsorAshley Downs Bioscience

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-01