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
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 Tomaevič
tanjatomazevic@gmail.com
Contact information
Scientific
Frankopanska ulica 8
ljubljana
1000
Slovenia
Study information
| Study design | Single centre double blind randomised placebo controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 01/07/2007 |
| Completion date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Paediatric patients, aged 1-19 years, who had been diagnosed with cancer and had started chemotherapy 2. Informed consent |
| Key exclusion criteria | 1. Allergy to propolis 2. Pre-diagnosed oral disease or therapy for oral disease |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/07/2013 |
Locations
Countries of recruitment
- Slovenia
Study participating centre
1000
Slovenia
Sponsor information
Hospital/treatment centre
Zaloka cesta 7
Ljubljana
1000
Slovenia
| Website | http://www4.kclj.si/ |
|---|---|
"ROR" |
https://ror.org/01nr6fy72 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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
