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:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01758562
First received: December 24, 2012
Last updated: August 14, 2014
Last verified: August 2014
  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 ]

Enrollment: 72
Study Start Date: January 2013
Study Completion Date: August 2014
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
University Hospital Zurich, Centre of Clinical Nursing Science
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: August 14, 2014
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on August 28, 2014