Condition category
Digestive System
Date applied
18/07/2012
Date assigned
07/09/2012
Last edited
07/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Chemotherapy for treating cancer can also cause swelling in the oral cavity (mouth) called oral mucositis, which is usually painful and can make eating, speaking or even sleeping difficult. Bacteria from the oral cavity can easily make their way into the blood stream and cause infections (bacteremia) or even blood poisoning (sepsis). Propolis is an easily available remedy, which patients often use for treating oral mucositis. We were trying to find out if we can reduce the incidence, duration and severity of oral mucositis, and if we can reduce the number of bacteremias caused by oral bacteria, if we asked patients to apply propolis to oral mucosa.

Who can participate?
Children diagnosed with cancer and treated with chemotherapy.

What does the study involve?
Regular check-ups of patients’ oral mucosa status after propolis applications and teeth brushing while on chemotherapy and analysis of blood samples for oral bacteria.

What are the possible benefits and risks of participating?
Patients gain instructions on proper teeth brushing and due to supervision also immediate correction of improper habits. At the end of the study, patients and medical staff gain the information on propolis effectiveness in oral mucositis treatment. There are no risks for the patients.

Where is the study run from?
Division of Oncology and Haematology, University Children's Hospital, Medical Centre Ljubljana.

When is study starting and how long is it expected to run for?
The study started in July 2007 and it is expected to be finished in July 2013.

Who is funding the study?
University Medical Centre Ljubljana, Slovenia.

Who is the main contact?
Tanja Tomaževič
tanjatomazevic@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Tanja Tomaževič

ORCID ID

Contact details

Frankopanska ulica 8
ljubljana
1000
Slovenia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A double blind randomised placebo controlled study of propolis effectiveness in the prevention and treatment of oral mucositis and in the prevention of bacteremia during oral mucositis in chemotherapy treated children

Acronym

Study hypothesis

Propolis applications on oral mucosa in chemotherapy treated children could:
1. Prevent oral mucositis
2. Shorten the duration and severity of oral mucositis
3. Reduce the incidence of viridans streptococcal bacteremia

Ethics approval

National Medical Ethics Committee, Ministry of Health of the Republic of Slovenia, 28 August 2007, ref:128/03/07.
Update approved 10 June 2009, ref: 49/09/09

Study design

Single centre double blind randomised placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chemotherapy induced oral mucositis

Intervention

Oral care protocol:
1. To apply the propolis or placebo to the vestibular oral mucosa using a Micro tip applicator
2. To brush teeth twice daily, using a soft toothbrush (Curapx, Curaden International AG, Kriens, Switzerland) and fluoride tooth paste (Colgate-Palmolive Company, New York City, New York, USA) provided to patients free of charge.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Mucositis episodes frequency, mucositis episodes mean duration and mucositis episodes mean severity, assessed with modified Oral assessment guide (1=normal, 3=severe mucositis) for the period of the chemotherapy if it lasts less than 6 months or for the first 6 months of the chemotherapy.
2. Cases of bacteremia during oral mucositis episodes

Secondary outcome measures

1. Number of total parenteral infusions
2. Analgesics during oral mucositis

Overall trial start date

01/07/2007

Overall trial end date

01/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Paediatric patients, aged 1-19 years, who had been diagnosed with cancer and had started chemotherapy
2. Informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Allergy to propolis
2. Pre-diagnosed oral disease or therapy for oral disease

Recruitment start date

01/07/2007

Recruitment end date

01/07/2013

Locations

Countries of recruitment

Slovenia

Trial participating centre

Frankopanska ulica 8
ljubljana
1000
Slovenia

Sponsor information

Organisation

University Medical Centre Ljubljana (Slovenia)

Sponsor details

Zaloška cesta 7
Ljubljana
1000
Slovenia

Sponsor type

Hospital/treatment centre

Website

http://www4.kclj.si/

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Ljubljana (Slovenia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes