Efficacy of Propolis in the Prevention of Oral Mucositis (OM)

Karadeniz Technical University

Status: Completed

Conditions: Oral Mucositis

Treatments: Other: Aqueous propolis extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05250661

E.6289

Details and patient eligibility

About

The study was carried out to determine the efficacy of propolis in the prevention of oral mucositis and gastrointestinal symptoms associated with oral mucositis in patients with leukemia, lymphoma, and myelodysplastic syndrome receiving high-dose chemotherapy and/or hematopoietic stem cell transplantation. 64 patients, 32 in the propolis and 32 in the control group, were involved in the prospective randomized controlled experimental study. While the standard oral care treatment protocol of the clinic was administered to the control group, aqueous propolis extract was applied to the propolis group in addition to the standard oral care treatment protocol.

Full description

Objective: The study was carried out to determine the efficacy of propolis in the prevention of oral mucositis and gastrointestinal symptoms associated with oral mucositis in patients with leukemia, lymphoma, and myelodysplastic syndrome receiving high-dose chemotherapy and/or hematopoietic stem cell transplantation.

Study Design:

The study was conducted as a randomized controlled experimental study. Approval from the Ethics Committee and written permission from the Institution were obtained. After the participants were informed about the purpose of the study, their written consents were obtained. 64 patients, 32 in the propolis and 32 in the control group were involved in the study that was performed in the Hematology and Bone Marrow Transplantation Unit.

The control group patients used the standard oral care treatment protocol (Tanflex (3x1) and NaHCO3 (1x1)) of the clinic , while the propolis group used the aqueous extract of propolis in addition to this protocol. The individuals in the propolis group gargled 4 times a day (after meals and before going to bed at night) with 5 ml aqueous propolis extract. All patients underwent a daily intraoral examination up to 21 days from the start of high dose chemotherapy. Oral mucositis was recorded on the WHO oral toxicity scale and other gastrointestinal symptoms were recorded on the National Cancer Institute-Common Terminology Criteria for Adverse Events scale

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Ability to communicate verbally
• Not having a diagnosed psychiatric disease
• Receiving inpatient high dose chemotherapy (diagnosed with leukemia, lymphoma and MDS)
• Hematopoietic Stem Cell Transplantation patients
• Zero OM score according to the World Health Organization Oral Toxicity Scale (WHOOTS)
• Karnofsky Performance Scale (KPS) score of 80 and above

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Aqueous propolis extract

Experimental group

Description:

The individuals in the intervention group were asked to gargle with 5 ml aqueous propolis extract four times a day after meals (morning, noon, evening and night before bedtime) and wait average one minute in the mouth and then spit, in addition to the standard practice of the clinic. According to the standard practice of the clinic, it was performed tanflex (3x1) and/or sodium bicarbonate (1x1) to the patients in the prevention of oral mucositis with the request of the physician. The patients were followed for 21 days. The 21-day period is consistent with the duration of mucositis healing in the literature. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday.

Treatment:

Other: Aqueous propolis extract

Control

No Intervention group

Description:

Standard procedures of the clinic were applied to control group. According to the standard practice of the clinic, it was performed tanflex (3x1) and/or sodium bicarbonate (1x1) to the patients in the prevention of oral mucositis with the request of the physician. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday.