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®

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT01758562

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Allogeneic Stem Cell Transplantation	Device: Caphosol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Duration of oral mucositis [20-30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT01758562

Other Study ID Numbers:

Capo

First Posted:

Jan 1, 2013

Last Update Posted:

Aug 15, 2014

Last Verified:

Aug 1, 2014

Study Results

No Results Posted as of Aug 15, 2014