Research with human participants

Overview of medical research in the Netherlands

Caphosol, a therapeutic option in cancer therapy induced mucositis in children.

Published:
Last updated:

Main objective: To assess the effect of Caphosol on the number of days of mucositis > grade ISecondary objective: to assess the effect of Caphosol on duration and degree of mucositis and pain, a possible influence on the occurrence of infections…

Download: PDF | XML
Ethical review
Approved WMO
Status
Pending
Health condition type
Other condition
Study type
Interventional

ID

NL-OMON35477

Source

ToetsingOnline

Brief title

Caphosol and mucositits.

Condition

  • Other condition

Synonym

denture sore mouth., Stomatitis

Health condition

mucositis

Research involving

Human

Sponsors and support

Primary sponsor :
Universitair Medisch Centrum Groningen
Source(s) of monetary or material Support :
Ministerie van OC&W,Eusapharma,Eusapharma;geen bemoeienis met studie behoudens financiele vergoeding deelnemende centra

Intervention

Keyword :
Caphosol, Children, Mucositis

Outcome measures

Primary outcome

Duration of mucositis.

Secondary outcome

Pain.

Background summary

Up to now it is unknown how the severity and the duration of mucositis can be
influenced in a positive way. At the moment mucositis is treated with NaCl 0,9%
mouth rinse. Recently they produced a new mouth rinse: Caphosol.
A trial in adults in the USA showed us that the intensity and duration of
mucositis can be reduced with Caphosol.
The UMCG initiated a study with Caphosol in oncological pediatric patients.
The study will be carried out in 4 academic children hospitals. When the study
proves that treatment with Caphosol reduces the duration and the pain, Caphosol
will be the standard treatment in the Netherlands.

Study objective

Main objective:
To assess the effect of Caphosol on the number of days of mucositis > grade I
Secondary objective: to assess the effect of Caphosol on duration and degree of
mucositis and pain, a possible influence on the occurrence of infections and
the *tolerability of Caphosol.

Study design

Investigator initiated multi center prospective double blind randomized
controlled trial

Intervention

Mouth rinse.

Study burden and risks

Minimal.

Public
Universitair Medisch Centrum Groningen

Postbus 30 001
9700 RB Groningen
NL
Scientific
Universitair Medisch Centrum Groningen

Postbus 30 001
9700 RB Groningen
NL

Listed location countries

Netherlands

Age

Adolescents (12-15 years)
Adolescents (16-17 years)
Children (2-11 years)

Inclusion criteria

Cancer therapy induced mucositis
Hospitalization
Age 4-18 years

Exclusion criteria

Previous Caphosol use
Previous study participation

Design

Study phase :
3
Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Pending
Start date (anticipated) :
Enrollment :
30
Type :
Anticipated

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Universitair Medisch Centrum Groningen (Groningen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

ID: 24436
Source: Nationaal Trial Register
Title: Onderzoek naar de werkzaamheid van Caphosol tegen mucositis bij kinderen met kanker.

In other registers

Register ID
CCMO NL29501.042.09
OMON NL-OMON24436