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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
64
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.
Karadeniz Technical University
Trabzon, Turkey (Türkiye)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From day 1 to day 21 of chemotherapy
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
Time frame: From day 1 to day 21 of chemotherapy
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
Time frame: From day 1 to day 21 of chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: From day 1 to day 21 of chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: From day 1 to day 21 of chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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
Time frame: For 21 days from the beginning of the chemotherapy
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