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®
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
- Duration of oral mucositis [ Time Frame: 20-30 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|No Intervention: State-of-the-art mouth care|
Active Comparator: Mouth rinse 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758562
|Contact: Anja Katharina Kroener||+41 (0)44 255 11 email@example.com|
|Contact: Rebecca Spirig, Prof MDfirstname.lastname@example.org|
|University Hospital Zurich, Centre of Clinical Nursing Science||Recruiting|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Rebecca Spirig, Prof MD||University Hospital Zurich, Centre of Clinical Nursing Science|