Determination of the Effectiveness of Propolis in the Prevention of Oral Mucositis in Patients Receiving High Dose Chemotherapy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Severity of oral mucositis
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
No masking
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Severity of oral mucositis
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Severity of dry mouth(For 21 days from the beginning of the chemotherapy)
- Incidence of nausea(For 21 days from the beginning of the chemotherapy)
- Time to onset of sensitivity/pain in the gums(From day 1 to day 21 of chemotherapy)
- 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)
- The duration of dry mouth(For 21 days from the beginning of the chemotherapy)
- Time to onset of nausea(From day 1 to day 21 of chemotherapy)
- Severity of nausea(For 21 days from the beginning of the chemotherapy)
- Incidence of sensitivity/pain in the gums(For 21 days from the beginning of the chemotherapy)
- Time to onset of pain in the oral mucosa(For 21 days from the beginning of the chemotherapy)
- Severity of dysphagia(For 21 days from the beginning of the chemotherapy)
- The duration of nausea(For 21 days from the beginning of the chemotherapy)
- Severity of sensitivity/pain in the gums(For 21 days from the beginning of the chemotherapy)
- The duration of sensitivity/pain in the gums(For 21 days from the beginning of the chemotherapy)
- Incidence of pain in the oral mucosa(For 21 days from the beginning of the chemotherapy)
- The duration of pain in the oral mucosa(For 21 days from the beginning of the chemotherapy)
- Time to onset of dysphagia(For 21 days from the beginning of the chemotherapy)
- Incidence of dysphagia(For 21 days from the beginning of the chemotherapy)
- Time to onset of esophagitis(For 21 days from the beginning of the chemotherapy)
- Severity of pain in the oral mucosa(For 21 days from the beginning of the chemotherapy)
- The duration of dysphagia(For 21 days from the beginning of the chemotherapy)
- Incidence of esophagitis(For 21 days from the beginning of the chemotherapy)
- Severity of esophagitis(For 21 days from the beginning of the chemotherapy)
- The duration of esophagitis(For 21 days from the beginning of the chemotherapy)
- Severity of diarrhea(For 21 days from the beginning of the chemotherapy)
- Severity of weight loss(For 21 days from the beginning of the chemotherapy)
- The duration of weight loss(For 21 days from the beginning of the chemotherapy)
- Time to onset of diarrhea(For 21 days from the beginning of the chemotherapy)
- Incidence of diarrhea(For 21 days from the beginning of the chemotherapy)
- The duration of diarrhea(For 21 days from the beginning of the chemotherapy)
- Time to onset of weight loss(For 21 days from the beginning of the chemotherapy)
- Incidence of weight loss(For 21 days from the beginning of the chemotherapy)
Investigators
Seher Çakmak
Assistant Professor
Karadeniz Technical University