Efficacy of Propolis in the Prevention of Oral Mucositis

NCT05250661 | Completed

• 1 other identifier: E.6289
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Mucositis

Keywords

Oral Mucositis; Propolis; High Dose Chemotherapy

Outcome Measures

Primary Outcomes (4)

• Time to onset of oral mucositis

  Time to onset of oral mucositis was be evaluated by the World Health Organization Oral Toxicity Scale which record the extent and severity of oral mucositis every day. The World Health Organization Oral Toxicity Scale: range 0 to 4, Grade 0; none, Grade 1; mild, Grade 2; moderate, Grade 3; severe, Grade 4; life threatening

  For 21 days from the beginning of the chemotherapy

• Incidence of oral mucositis

  Incidence of oral mucositis was be evaluated by the World Health Organization Oral Toxicity Scale which record the extent and severity of oral mucositis every day. The World Health Organization Oral Toxicity Scale: range 0 to 4, Grade 0; none, Grade 1; mild, Grade 2; moderate, Grade 3; severe, Grade 4; life threatening

  For 21 days from the beginning of the chemotherapy

• Severity of oral mucositis

  Severity of oral mucositis was be evaluated by the World Health Organization Oral Toxicity Scale which record the extent and severity of oral mucositis every day. The World Health Organization Oral Toxicity Scale: range 0 to 4, Grade 0; none, Grade 1; mild, Grade 2; moderate, Grade 3; severe, Grade 4; life threatening

  For 21 days from the beginning of the chemotherapy

• The duration of oral mucositis

  The duration of oral mucositis was be evaluated by the World Health Organization Oral Toxicity Scale which record the extent and severity of oral mucositis every day. The World Health Organization Oral Toxicity Scale: range 0 to 4, Grade 0; none, Grade 1; mild, Grade 2; moderate, Grade 3; severe, Grade 4; life threatening

  From day 1 to day 21 of chemotherapy

Secondary Outcomes (33)

• Time to onset of at least grade 2 oral mucositis

  From day 1 to day 21 of chemotherapy

• Time to onset of dry mouth

  From day 1 to day 21 of chemotherapy

• Incidence of dry mouth

  For 21 days from the beginning of the chemotherapy

• Severity of dry mouth

  For 21 days from the beginning of the chemotherapy

• The duration of dry mouth

  For 21 days from the beginning of the chemotherapy

Study Arms (2)

Aqueous propolis extract

EXPERIMENTAL

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.

Other: Aqueous propolis extract

Control

NO INTERVENTION

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.

Interventions

Aqueous propolis extract OTHER

The patients gargled 4 times a day after meals and 5 ml each time. Patients were instructed to keep the propolis solution in their mouth for one minute, to touch all structures in the mouth, and not to eat or drink anything orally for one hour after spitting.

Aqueous propolis extract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, 61000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Seher ÇAKMAK Karadeniz Technical University

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel group, two arm, prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 22, 2022
• Study Start: May 15, 2019
• Primary Completion: September 22, 2020
• Study Completion: May 29, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

TU (1)