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®

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allogeneic Stem Cell Transplantation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Centre of Clinical Nursing Science

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caphosol

Device

Primary outcomes

Duration of oral mucositis

Time frame: 20-30 days

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jan 1, 2013
Registry last updated: Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed