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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®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758562
First Posted: January 1, 2013
Last Update Posted: August 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
December 24, 2012
January 1, 2013
August 15, 2014
January 2013
August 2014   (Final data collection date for primary outcome measure)
Duration of oral mucositis [ Time Frame: 20-30 days ]
Same as current
Complete list of historical versions of study NCT01758562 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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 Provided

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Allogeneic Stem Cell Transplantation
Device: Caphosol
  • 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.
    Intervention: Device: Caphosol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Allogeneic stem cell transplantation
  • Male and female patients age 18-80
  • Signed informed consent after information

Exclusion criteria:

  • Contra-indications due to ethical reasons
  • Unable to read or write
  • Unable to speak or understand the german language
  • Low-salt diet
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01758562
Capo
Yes
Not Provided
Not Provided
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Rebecca Spirig, Prof MD University Hospital Zurich, Centre of Clinical Nursing Science
University of Zurich
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP