Oral Complications in Hematological Malignancies

Hematologic Malignancy Clinical Trial

Official title:

Prevalence and Types of Oral Complications Occuring in Hematological Malignancy Patients.:Cross Sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758207
• Other study ID #: Hematology malignancies
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: Merit Rafeek
• Phone: 01270240012
• Email: toot.rafeek[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study was to evaluate the prevalence and types of oral complications found in patients diagnosed with haematological malignancy

Description:

Oral lesions can be the first presentation of hematological malignancy. Dentists occasionally are the first healthcare provider that detect oral signs related to a systemic condition and thus contribute to the early diagnosis of the disease 1. Oral health can impact the progression and the outcome of haematological malignancy patients', many patients may suffer from oral infections that might affect hospital stay, treatment cost and patient prognosis 2. The oral manifestations of patients with hematological malignancy can occur due to the disease itself or as a consequence of treatment 3.

Anemia (paleness of mucosa), coagulation disorder, oral petechiae or ecchymosis, spontaneous gingival bleeding and oral infection (Ulcers and overgrowth) may be an oral manifestation of a hematologic malignancy either at diagnosis or during follow up as well as in relapse 4. The treatment of hematologic malignancy includes chemotherapy, radiotherapy, and hematopoietic stem cell transplantation (HSCT). Malignant cells are the target of antineoplastic drugs, but the oral epithelium and other cells with high mitotic rates are usually affected by the treatment. Chemotherapy and the conditioning regimen for HSCT have many adverse effects on the oral tissues depending on the type and dosage of medications 4. Oral mucositis, a common side effect of chemotherapy, causes severe pain, which is only relieved by opioids. Mucositis may appear as a generalized erythema and evolve into painful pseudomembranous ulcers. Neutropenia and thrombocytopenia are also common adverse effects of treatment, leaving patients more susceptible to oral bleeding, infections, and ulcerations. Oral mucosa pigmentation can also occur as an adverse effect of treatment 5. Considering these factors and lack of existing information, a study was designed to investigate the prevalence of oral complications problems occurring in a population of hematological malignancy patients in Assiut University Hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All newly diagnosed patients elder than 18 years with hematological malignancy start from January 1st 2022 to January 1st 2023 including Acute myeloid leukemia Acute lymphoblastic leukemia Chronic myeloid leukemia Chronic lymphoblastic leukemia Non-Hodgkin lymphoma Hodgkin lymphoma Multiple myeloma

Exclusion Criteria:

• Patient younger than 18 years old Patients previously diagnosed Patients refused to participate in our study

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Elad S, Zadik Y, Yarom N. Oral Complications of Nonsurgical Cancer Therapies. Atlas Oral Maxillofac Surg Clin North Am. 2017 Sep;25(2):133-147. doi: 10.1016/j.cxom.2017.04.006. No abstract available. — View Citation

Emodi O, Ohayon C, Bilder A, Capucha T, Wolff A, Rachmiel A. Postextraction Mucormycosis in Immunocompromised-Patient Management and Review of Literature. J Oral Maxillofac Surg. 2021 Jul;79(7):1482-1491. doi: 10.1016/j.joms.2021.01.019. Epub 2021 Jan 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculate the prevalence of oral complications.	Calculate the prevalence of oral complications with special attention to infectious complications in hematological malignancy patients.	Baseline
Secondary	the morbidity related to oral complication in haematological malignancy patients.	Study the morbidity related to oral complication in haematological malignancy patients.	Baseline