ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - Pr… (NCT02016807) | Clinical Trial Compass
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 range
18 Years – 95 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Change from Baseline in Oral Mucositis Assessment Score (OMAS) at Day 1, 2,4,7,14,21