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®

Allogeneic Stem Cell Transplantation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758562
• Other study ID #: Capo
• Status: Completed
• Phase: N/A
• First received: December 24, 2012
• Last updated: August 14, 2014
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplantation

Intervention

Device:
• Caphosol

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Centre of Clinical Nursing Science	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of oral mucositis		20-30 days	No