Caphosol® Versus State-of-the-art Mouthcare in Patients With Allogeneic Stem Cell Transplantation: a Randomized Controlled Study About the Efficacy of the Mouth Rinse Caphosol®
Not Applicable
Completed
- Conditions
- Allogeneic Stem Cell Transplantation
- Interventions
- Device: Caphosol
- Registration Number
- NCT01758562
- Lead Sponsor
- University of Zurich
- Brief Summary
Randomized controlled study about the efficacy of the mouth rinse Caphosol in patients with allogeneic stem cell transplantation. 85% of the patients receive a severe oral mucositis due to their treatment.
70 patients will be randomized in the intervention (Caphosol) or in the standard (state-of-the-art) group. Primary endpoint is the duration of the mucositis, secondary endpoints are the occurence of oral mucositis measured with the WHO-scale and the occurence of pain measured with the NRS-scale (Numeric Rating Scale).
* Trial with medical device
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Not provided
Read More
Exclusion Criteria
Not provided
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mouth rinse Caphosol Caphosol Mouth rinse,aqueous solution. Caphosol is a preparation comprising two separately packaged aqueous solutions, a phosphate solution and a calcium solution, which, when both solutions are combined in equal volumes, forms a solution supersaturated with respect to both calcium and phosphate ions.
- Primary Outcome Measures
Name Time Method Duration of oral mucositis 20-30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Zurich, Centre of Clinical Nursing Science
🇨🇭Zurich, ZH, Switzerland