The effect of propolis on chemotherapy induced oral mucositis and bacteremia during oral mucositis

ISRCTN ISRCTN47055000
DOI https://doi.org/10.1186/ISRCTN47055000
Secondary identifying numbers N/A
Submission date
18/07/2012
Registration date
07/09/2012
Last edited
22/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Tanja Tomaževič
Scientific

Frankopanska ulica 8
ljubljana
1000
Slovenia

Study information

Study designSingle centre double blind randomised placebo controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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
Study objectivesPropolis 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(s)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
Health condition(s) or problem(s) studiedChemotherapy induced oral mucositis
InterventionOral 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 typeOther
Primary outcome measure1. 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 measures1. Number of total parenteral infusions
2. Analgesics during oral mucositis
Overall study start date01/07/2007
Completion date01/07/2013

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit19 Years
SexBoth
Target number of participants50
Key inclusion criteria1. Paediatric patients, aged 1-19 years, who had been diagnosed with cancer and had started chemotherapy
2. Informed consent
Key exclusion criteria1. Allergy to propolis
2. Pre-diagnosed oral disease or therapy for oral disease
Date of first enrolment01/07/2007
Date of final enrolment01/07/2013

Locations

Countries of recruitment

  • Slovenia

Study participating centre

Frankopanska ulica 8
ljubljana
1000
Slovenia

Sponsor information

University Medical Centre Ljubljana (Slovenia)
Hospital/treatment centre

Zaloška cesta 7
Ljubljana
1000
Slovenia

Website http://www4.kclj.si/
ROR logo "ROR" https://ror.org/01nr6fy72

Funders

Funder type

Hospital/treatment centre

University Medical Centre Ljubljana (Slovenia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2013 22/01/2019 Yes No

Editorial Notes

22/01/2019: Publication reference added