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 Tomaevič
tanjatomazevic@gmail.com
Trial website
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 measure
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 (if study stopped)
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
Zaloka cesta 7
Ljubljana
1000
Slovenia
Sponsor type
Hospital/treatment centre
Website
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
Basic results (scientific)
Publication list
1. 2013 results in https://www.ncbi.nlm.nih.gov/pubmed/23876561 (added 22/01/2019)