Clinical trial NCT05250661: Efficacy of Propolis in the Prevention of Oral Mucositis
Official title: Determination of the Effectiveness of Propolis in the Prevention of Oral Mucositis in Patients Receiving High Dose Chemotherapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Keywords: Oral Mucositis
Propolis
High Dose Chemotherapy
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, two arm, prospective randomized controlled clinical trial
Primary purpose: PREVENTION

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

Eligibility criteria: 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:

-

Primary outcomes:
measure: Time to onset of oral mucositis
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Incidence of oral mucositis
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Severity of oral mucositis
timeFrame: For 21 days from the beginning of the chemotherapy
measure: The duration of oral mucositis
timeFrame: From day 1 to day 21 of chemotherapy
Secondary outcomes:
measure: Time to onset of at least grade 2 oral mucositis
timeFrame: From day 1 to day 21 of chemotherapy
measure: Time to onset of dry mouth
timeFrame: From day 1 to day 21 of chemotherapy
measure: Incidence of dry mouth
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Severity of dry mouth
timeFrame: For 21 days from the beginning of the chemotherapy
measure: The duration of dry mouth
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Time to onset of nausea
timeFrame: From day 1 to day 21 of chemotherapy
measure: Incidence of nausea
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Severity of nausea
timeFrame: For 21 days from the beginning of the chemotherapy
measure: The duration of nausea
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Time to onset of sensitivity/pain in the gums
timeFrame: From day 1 to day 21 of chemotherapy
measure: Incidence of sensitivity/pain in the gums
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Severity of sensitivity/pain in the gums
timeFrame: For 21 days from the beginning of the chemotherapy
measure: The duration of sensitivity/pain in the gums
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Time to onset of pain in the oral mucosa
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Incidence of pain in the oral mucosa
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Severity of pain in the oral mucosa
timeFrame: For 21 days from the beginning of the chemotherapy
measure: The duration of pain in the oral mucosa
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Time to onset of dysphagia
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Incidence of dysphagia
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Severity of dysphagia
timeFrame: For 21 days from the beginning of the chemotherapy
measure: The duration of dysphagia
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Time to onset of esophagitis
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Incidence of esophagitis
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Severity of esophagitis
timeFrame: For 21 days from the beginning of the chemotherapy
measure: The duration of esophagitis
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Time to onset of diarrhea
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Incidence of diarrhea
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Severity of diarrhea
timeFrame: For 21 days from the beginning of the chemotherapy
measure: The duration of diarrhea
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Time to onset of weight loss
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Incidence of weight loss
timeFrame: For 21 days from the beginning of the chemotherapy
measure: Severity of weight loss
timeFrame: For 21 days from the beginning of the chemotherapy
measure: The duration of weight loss
timeFrame: For 21 days from the beginning of the chemotherapy
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: Seher ÇAKMAK Karadeniz Technical University
role: PRINCIPAL_INVESTIGATOR
References: