Efficacy of Propolis in the Prevention of Oral Mucositis

Not Applicable

Completed

• Conditions: Oral Mucositis
• Interventions: Other: Aqueous propolis extract

• Registration Number: NCT05250661
• Lead Sponsor: Karadeniz Technical University

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.

Detailed 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

Study Timeline

• Study Start: 2019-05-15
• Primary Completion: 2020-09-22
• Study Completion: 2021-05-29
• Study First Submitted: 2022-01-24
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-20
• Last Update Submitted: 2022-02-20
• Study First Posted: 2022-02-22
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aqueous propolis extract	Aqueous propolis extract	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.

Primary Outcome Measures

Name	Time	Method
Severity of oral mucositis	For 21 days from the beginning of the chemotherapy	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
Time to onset of oral mucositis	For 21 days from the beginning of the chemotherapy	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
Incidence of oral mucositis	For 21 days from the beginning of the chemotherapy	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
The duration of oral mucositis	From day 1 to day 21 of chemotherapy	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

Secondary Outcome Measures

Name	Time	Method
Severity of dry mouth	For 21 days from the beginning of the chemotherapy	Severity of dry mouth was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Incidence of nausea	For 21 days from the beginning of the chemotherapy	Incidence of nausea was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Time to onset of sensitivity/pain in the gums	From day 1 to day 21 of chemotherapy	Time to onset of sensitivity/pain in the gums was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Time to onset of at least grade 2 oral mucositis	From day 1 to day 21 of chemotherapy	Time to onset of at least grade 2 oral mucositis was be evaluated by the World Health Organization Scale which record the extent and severity of oral mucositis every day.; The World Health Organization Oral Toxicity Scale: Grade 2; moderate, Grade 3; severe and Grade 4; life threatening
Time to onset of dry mouth	From day 1 to day 21 of chemotherapy	Time to onset of dry mouth was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Incidence of dry mouth	For 21 days from the beginning of the chemotherapy	Incidence of dry mouth was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
The duration of dry mouth	For 21 days from the beginning of the chemotherapy	The duration of dry mouth was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Time to onset of nausea	From day 1 to day 21 of chemotherapy	Time to onset of nausea was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Severity of nausea	For 21 days from the beginning of the chemotherapy	Severity of nausea was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Incidence of sensitivity/pain in the gums	For 21 days from the beginning of the chemotherapy	Incidence of sensitivity/pain in the gums was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Time to onset of pain in the oral mucosa	For 21 days from the beginning of the chemotherapy	Time to onset of pain in the oral mucosa was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Severity of dysphagia	For 21 days from the beginning of the chemotherapy	Severity of dysphagia was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
The duration of nausea	For 21 days from the beginning of the chemotherapy	The duration of nausea was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Severity of sensitivity/pain in the gums	For 21 days from the beginning of the chemotherapy	Severity of sensitivity/pain in the gums was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
The duration of sensitivity/pain in the gums	For 21 days from the beginning of the chemotherapy	The duration of sensitivity/pain in the gums was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Incidence of pain in the oral mucosa	For 21 days from the beginning of the chemotherapy	Incidence of pain in the oral mucosa was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
The duration of pain in the oral mucosa	For 21 days from the beginning of the chemotherapy	The duration of pain in the oral mucosa was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Time to onset of dysphagia	For 21 days from the beginning of the chemotherapy	Time to onset of dysphagia was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
Incidence of dysphagia	For 21 days from the beginning of the chemotherapy	Incidence of dysphagia was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
Time to onset of esophagitis	For 21 days from the beginning of the chemotherapy	Time to onset of esophagitis was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
Severity of pain in the oral mucosa	For 21 days from the beginning of the chemotherapy	Severity of pain in the oral mucosa was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
The duration of dysphagia	For 21 days from the beginning of the chemotherapy	The duration of dysphagia was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
Incidence of esophagitis	For 21 days from the beginning of the chemotherapy	Incidence of esophagitis was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
Severity of esophagitis	For 21 days from the beginning of the chemotherapy	Severity of esophagitis was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
The duration of esophagitis	For 21 days from the beginning of the chemotherapy	The duration of esophagitis was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
Severity of diarrhea	For 21 days from the beginning of the chemotherapy	Severity of diarrhea was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
Severity of weight loss	For 21 days from the beginning of the chemotherapy	Severity of weight loss was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
The duration of weight loss	For 21 days from the beginning of the chemotherapy	The duration of weight loss was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Time to onset of diarrhea	For 21 days from the beginning of the chemotherapy	Time to onset of diarrhea was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
The duration of diarrhea	For 21 days from the beginning of the chemotherapy	The duration of diarrhea was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death
Time to onset of weight loss	For 21 days from the beginning of the chemotherapy	Time to onset of weight loss was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Incidence of weight loss	For 21 days from the beginning of the chemotherapy	Incidence of weight loss was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 3, 1 was the mild, 3 was the severe
Incidence of diarrhea	For 21 days from the beginning of the chemotherapy	Incidence of diarrhea was be evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events Scale which to describe the severity of organ toxicity for patients receiving cancer therapy every day.; The National Cancer Institute Common Terminology Criteria for Adverse Events Scale: Range 1 to 5, 1 was the mild, 5 was the death

Trial Locations

Locations (1)

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey