Efficacy of Propolis in the Prevention of Oral Mucositis

Oral Mucositis Clinical Trial

— OM  

Official title:

Determination of the Effectiveness of Propolis in the Prevention of Oral Mucositis in Patients Receiving High Dose Chemotherapy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05250661
• Other study ID #: E.6289
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: May 29, 2021

Study information

• Verified date: February 2022
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 29, 2021
• Est. primary completion date: September 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Other:
• Aqueous propolis extract
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.

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Time to onset of at least grade 2 oral mucositis	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	From day 1 to day 21 of chemotherapy
Secondary	Time to onset of dry mouth	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	From day 1 to day 21 of chemotherapy
Secondary	Incidence of dry mouth	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	For 21 days from the beginning of the chemotherapy
Secondary	Severity of dry mouth	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	For 21 days from the beginning of the chemotherapy
Secondary	The duration of dry mouth	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	For 21 days from the beginning of the chemotherapy
Secondary	Time to onset of nausea	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	From day 1 to day 21 of chemotherapy
Secondary	Incidence of nausea	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	For 21 days from the beginning of the chemotherapy
Secondary	Severity of nausea	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	For 21 days from the beginning of the chemotherapy
Secondary	The duration of nausea	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	For 21 days from the beginning of the chemotherapy
Secondary	Time to onset of sensitivity/pain in the gums	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	From day 1 to day 21 of chemotherapy
Secondary	Incidence of sensitivity/pain in the gums	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	For 21 days from the beginning of the chemotherapy
Secondary	Severity of sensitivity/pain in the gums	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	For 21 days from the beginning of the chemotherapy
Secondary	The duration of sensitivity/pain in the gums	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	For 21 days from the beginning of the chemotherapy
Secondary	Time to onset of pain in the oral mucosa	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	For 21 days from the beginning of the chemotherapy
Secondary	Incidence of pain in the oral mucosa	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	For 21 days from the beginning of the chemotherapy
Secondary	Severity of pain in the oral mucosa	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	For 21 days from the beginning of the chemotherapy
Secondary	The duration of pain in the oral mucosa	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	For 21 days from the beginning of the chemotherapy
Secondary	Time to onset of dysphagia	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	For 21 days from the beginning of the chemotherapy
Secondary	Incidence of dysphagia	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	For 21 days from the beginning of the chemotherapy
Secondary	Severity of dysphagia	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	For 21 days from the beginning of the chemotherapy
Secondary	The duration of dysphagia	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	For 21 days from the beginning of the chemotherapy
Secondary	Time to onset of esophagitis	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	For 21 days from the beginning of the chemotherapy
Secondary	Incidence of esophagitis	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	For 21 days from the beginning of the chemotherapy
Secondary	Severity of esophagitis	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	For 21 days from the beginning of the chemotherapy
Secondary	The duration of esophagitis	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	For 21 days from the beginning of the chemotherapy
Secondary	Time to onset of diarrhea	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	For 21 days from the beginning of the chemotherapy
Secondary	Incidence of diarrhea	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	For 21 days from the beginning of the chemotherapy
Secondary	Severity of diarrhea	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	For 21 days from the beginning of the chemotherapy
Secondary	The duration of diarrhea	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	For 21 days from the beginning of the chemotherapy
Secondary	Time to onset of weight loss	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	For 21 days from the beginning of the chemotherapy
Secondary	Incidence of weight loss	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	For 21 days from the beginning of the chemotherapy
Secondary	Severity of weight loss	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	For 21 days from the beginning of the chemotherapy
Secondary	The duration of weight loss	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	For 21 days from the beginning of the chemotherapy