Oral MucositisOMNCT05250661
Efficacy of Propolis in the Prevention of Oral Mucositis
A study testing Aqueous propolis extract in people with Oral Mucositis, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Aqueous propolis extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2019to 29 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effectiveness of Propolis in the Prevention of Oral Mucositis in Patients Receiving High Dose Chemotherapy: A Randomized Controlled Trial
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.
Read the 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
- Conditions
- Oral Mucositis
- Being tested
- Aqueous propolis extract
- Keywords
- Oral Mucositis, Propolis, High Dose Chemotherapy
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqueous propolis extractOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aqueous propolis extract | Experimental | 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. Receives: Other: Aqueous propolis extract |
| Control | No intervention | Standard procedures of the clinic were applied to control group. 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. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: From day 1 to day 21 of chemotherapy
Secondary outcomes (33)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: For 21 days from the beginning of the chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start15 May 2019
- Primary completion22 Sep 2020
- Study completion29 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, two arm, prospective randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Çakmak, Karadeniz Technical University
- Investigators
- Seher ÇAKMAK Karadeniz Technical University, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250661
- Sponsor's protocol ID
- E.6289
- Acronym
- OM
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effectiveness of Propolis in the Prevention of Oral Mucositis in Patients Receiving High Dose Chemotherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05250661
- Acronym / sponsor ID
- OM / E.6289
- Conditions
- Oral Mucositis
- Keywords
- Oral Mucositis, Propolis, High Dose Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 29 May 2021 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group, two arm, prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Aqueous propolis extract | Experimental | Other: Aqueous propolis extractThe 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. |
| Control | No intervention | –Standard procedures of the clinic were applied to control group. 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. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aqueous propolis extractThe 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. | Other | Aqueous propolis extract |
Primary outcome
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
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
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
33 secondary outcomes
Time to onset of at least grade 2 oral mucositis
Time frame: From day 1 to day 21 of chemotherapy
Time to onset of dry mouth
Time frame: From day 1 to day 21 of chemotherapy
Incidence of dry mouth
Time frame: For 21 days from the beginning of the chemotherapy
Severity of dry mouth
Time frame: For 21 days from the beginning of the chemotherapy
The duration of dry mouth
Time frame: For 21 days from the beginning of the chemotherapy
Time to onset of nausea
Time frame: From day 1 to day 21 of chemotherapy
Incidence of nausea
Time frame: For 21 days from the beginning of the chemotherapy
Severity of nausea
Time frame: For 21 days from the beginning of the chemotherapy
The duration of nausea
Time frame: For 21 days from the beginning of the chemotherapy
Time to onset of sensitivity/pain in the gums
Time frame: From day 1 to day 21 of chemotherapy
Incidence of sensitivity/pain in the gums
Time frame: For 21 days from the beginning of the chemotherapy
Severity of sensitivity/pain in the gums
Time frame: For 21 days from the beginning of the chemotherapy
The duration of sensitivity/pain in the gums
Time frame: For 21 days from the beginning of the chemotherapy
Time to onset of pain in the oral mucosa
Time frame: For 21 days from the beginning of the chemotherapy
Incidence of pain in the oral mucosa
Time frame: For 21 days from the beginning of the chemotherapy
Severity of pain in the oral mucosa
Time frame: For 21 days from the beginning of the chemotherapy
The duration of pain in the oral mucosa
Time frame: For 21 days from the beginning of the chemotherapy
Time to onset of dysphagia
Time frame: For 21 days from the beginning of the chemotherapy
Incidence of dysphagia
Time frame: For 21 days from the beginning of the chemotherapy
Severity of dysphagia
Time frame: For 21 days from the beginning of the chemotherapy
The duration of dysphagia
Time frame: For 21 days from the beginning of the chemotherapy
Time to onset of esophagitis
Time frame: For 21 days from the beginning of the chemotherapy
Incidence of esophagitis
Time frame: For 21 days from the beginning of the chemotherapy
Severity of esophagitis
Time frame: For 21 days from the beginning of the chemotherapy
The duration of esophagitis
Time frame: For 21 days from the beginning of the chemotherapy
Time to onset of diarrhea
Time frame: For 21 days from the beginning of the chemotherapy
Incidence of diarrhea
Time frame: For 21 days from the beginning of the chemotherapy
Severity of diarrhea
Time frame: For 21 days from the beginning of the chemotherapy
The duration of diarrhea
Time frame: For 21 days from the beginning of the chemotherapy
Time to onset of weight loss
Time frame: For 21 days from the beginning of the chemotherapy
Incidence of weight loss
Time frame: For 21 days from the beginning of the chemotherapy
Severity of weight loss
Time frame: For 21 days from the beginning of the chemotherapy
The duration of weight loss
Time frame: For 21 days from the beginning of the chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
Related trials for Oral Mucositis
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seher ÇAKMAK Karadeniz Technical University principal investigator
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqueous propolis extract in people with Oral Mucositis, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to onset of oral mucositis (time frame: For 21 days from the beginning of the chemotherapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.