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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 is not yet open for participant recruitment.
Verified December 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01758562
First received: December 24, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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

Condition Intervention
Allogeneic Stem Cell Transplantation
 Device: Caphosol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Duration of oral mucositis [ Time Frame: 20-30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
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)
Arms Assigned Interventions
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.
 Device: Caphosol

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758562

Contacts
Contact: Anja Katharina Kroener +41 (0)44 255 11 11 anja.kroener@usz.ch
Contact: Rebecca Spirig, Prof MD rebecca.spirig@usz.ch

Locations
Switzerland
University Hospital Zurich, Centre of Clinical Nursing Science Not yet recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Rebecca Spirig, Prof MD University Hospital Zurich, Centre of Clinical Nursing Science
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01758562     History of Changes
Other Study ID Numbers: Capo
Study First Received: December 24, 2012
Last Updated: December 24, 2012
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on May 19, 2013