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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47055000
Enrollment
50
Registered
2012-09-07
Start date
2007-07-01
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy induced oral mucositis Digestive System Oral mucositis

Interventions

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 toothbrus

Sponsors

University Medical Centre Ljubljana (Slovenia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Slovenia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026