Propolis for Management of Chemotherapy-Induced Oral Mucositis in Pediatric Patients

Ain Shams University

Status and phase: Not yet enrolling; Phase 2

Conditions: Oral Mucositis Due to Chemotherapy

Treatments: Drug: chlorohexidine mouthwash and topical antifungal; Drug: propolis

Study type: Interventional

Funder types: Other

Identifiers

NCT07073092

FDASU-Rec IR/D052520

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the efficacy of propolis in the prevention of oral mucositis and reducing pain score in children undergoing chemotherapy, and assessing its impact on body mass index, pediatric quality of life and total antioxidant assay. The main question it aims to answer is:

What is the effect of propolis on oral mucositis scores in children undergoing chemotherapy?

Participants will:

Take propolis 3 times daily for 21 days follow up weekly for 3 weeks

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children of both genders less than 18 years receiving intensive chemotherapy.

• Oncology patients receiving intensified chemotherapy at Oncology unit, Children's Hospital, Ain Shams University, Egypt, who meet the following criteria:

  • Taking intensified chemotherapy
  • A healthy oral mucosa.

Exclusion criteria

• Allergy to bee products.
• Severe systemic illness unrelated to cancer (Diabetes, Hypertension, ...)
• Inability to take oral medication or unwillingness to participate in the study
• Radiotherapy in the head and neck area.
• Malignant or potentially malignant lesions of the oral cavity.
• Undergoing any other procedures to prevent oral mucositis except standard oral care.
• Patients are unable to commit to the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

study group

Experimental group

Description:

propolis medicated jelly candy+ standard oral care (chlorohexidine and topical anti-fungal) three times daily for 21 days

Treatment:

Drug: propolis

Drug: chlorohexidine mouthwash and topical antifungal

control group

Active Comparator group

Description:

Standard oral care (chlorohexidine mouth wash and topical anti-fungal) three times daily for 21 days

Treatment:

Drug: chlorohexidine mouthwash and topical antifungal