Investigating some of the oral manifestations associated with neutropenia - a clinical cross-sectional study
| ISRCTN | ISRCTN17585958 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17585958 |
- Submission date
- 11/08/2023
- Registration date
- 06/09/2023
- Last edited
- 18/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
A lower number than usual of certain white blood cells (neutrophils) is termed neutropenia. Neutrophils are part of the immune system and neutropenia has many possible causes, either congenital or acquired, and chemotherapy is the most common. Neutropenia has a great effect on the oral cavity. Therefore, oral lesions and periodontal diseases can take the form of ulcers, infections, mucositis, gingivitis, and periodontitis. In addition, neutropenia may reduce the quality of life of these patients. This study aims to investigate the oral manifestations associated with chemotherapy-induced neutropenia in patients with hematological malignancies, to evaluate the role of neutropenia in the development of periodontal diseases and quality of life comparison between the neutropenic group and the non-neutropenic group.
Who can participate?
Patients with hematological malignancies undergoing chemotherapy
What does the study involve?
The study is an observational study that involves only a clinical examination after 2 weeks of starting a new chemotherapy course, in addition to a questionnaire about the patient's quality of life.
What are the possible benefits and risks of participating?
The benefits of this study are the early diagnosis of oral and periodontal lesions and receiving the appropriate treatment when needed, and there are no risks as no procedures are required.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
January 2021 to January 2023
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Fatima AlZahraa Al Beesh, fatimaalzahraa.albeesh@damascusuniversity.edu.sy
Contact information
Principal Investigator
Faculty of Dentistry
Damascus
00963
Syria
 ORCID ID |
0009-0008-9948-8689 |
|---|---|
| Phone | +963994621887 |
| fatimaalzahraa.albeesh@damascusuniversity.edu.sy |
Scientific
Faculty of Dentistry
Damascus
00963
Syria
| ORCID ID |
0000-0001-8606-3122 |
|---|---|
| Phone | +963944703131 |
| abeer79.aljoujou@damascusuniversity.edu.sy |
Public
Faculty of Dentistry
Damascus
00963
Syria
| Phone | +963994621887 |
|---|---|
| fatimaalzahraa.albeesh@damascusuniversity.edu.sy |
Study information
| Study design | Cross-sectional clinical observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Quality of life, Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Are patients undergoing chemotherapy who develop chemotherapy-induced neutropenia at greater risk for having oral lesions and periodontal diseases compared with patients without chemotherapy-induced neutropenia? |
| Study objectives | 1. Neutropenia leads to changes in the oral mucosa and the appearance of some oral lesions 2. Neutropenia affects the periodontium and leads to pathological changes 3. Neutropenia affects and decreases the patient's quality of life |
| Ethics approval(s) |
Approved 27/09/2021, The Scientific Research Committee of the Faculty of Dentistry of Damascus University (Faculty of Dentistry, Damascus University, Damascus City, 00963, Syria; +9631133923192 ; info@damascusuniversity.edu.sy), ref: 154 |
| Health condition(s) or problem(s) studied | Oral manifestations associated with neutropenia in patients with hematological malignancies undergoing chemotherapy |
| Intervention | The study sample consists of 50 patients divided into two groups as follows: the first group includes the hematological malignancies patients with chemotherapy-induced neutropenia (25 patients), and the second group includes the hematological malignancies patients without chemotherapy-induced neutropenia (25 patients). The patient is included in one of these groups depending on the absolute neutrophils count (ANC), after which a clinical dental examination is performed looking for the presence of oral lesions and periodontal diseases. In addition, a questionnaire is answered by patients to assess their quality of life. The patient is observed after 2 weeks from the beginning of the chemotherapy course, and no follow-up is required. |
| Intervention type | Other |
| Primary outcome measure | 1. Oral manifestations measured using clinical and visual diagnosis at a single timepoint 2. Periodontal diseases measured using clinical and visual diagnosis at a single timepoint 3. Quality of life measured using a questionnaire that concentrates on different aspects of life as a result of neutropenia/chemotherapy at a single timepoint |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 13/01/2021 |
| Completion date | 12/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | First group (patients with chemotherapy-induced neutropenia): 1. Patients diagnosed with hematological malignancy 2. Patients who received at least one cycle of chemotherapy 3. Patients developing neutropenia after chemotherapy, with an absolute neutrophil count (ANC) less than 1.5 x 10^9/L Second group (patients without chemotherapy-induced neutropenia): 1. Patients diagnosed with hematological malignancy 2. The patient has received at least one cycle of chemotherapy 3. The patient does not present with post-chemotherapy neutropenia, and has an ANC greater than 1.5 x 10^9/L |
| Key exclusion criteria | 1. Patients receive radiation therapy as part of their treatment 2. The patient has been diagnosed with oral cancer 3. The patient is diagnosed with a non-hematological malignancy 4. The patient is diagnosed with diabetes |
| Date of first enrolment | 24/10/2021 |
| Date of final enrolment | 31/08/2022 |
Locations
Countries of recruitment
- Syria
Study participating centres
Damascus Countryside
00963
Syria
Damascus
00963
Syria
Damascus
00963
Syria
Sponsor information
University/education
-
Damascus
00963
Syria
| Phone | +9631133923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 17/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact and peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Fatima AlZahraa Al Beesh (fatimaalzahraaalbeesh@gmail.com). Consent from participants was required and obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/03/2025 | 18/03/2025 | Yes | No |
Editorial Notes
18/03/2025: Publication reference added.
21/08/2023: Study's existence confirmed by Damascus University.
