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®

NCT ID: NCT01758562

Last Updated: 2014-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Allogeneic Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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State-of-the-art mouth care

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Caphosol

Intervention Type DEVICE

Interventions

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Caphosol

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Spirig, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Centre of Clinical Nursing Science

Locations

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University Hospital Zurich, Centre of Clinical Nursing Science

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Capo

Identifier Type: -

Identifier Source: org_study_id

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