Oral Complications in Hematological Malignancies

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05758207
Collaborator
(none)
100
1
7
14.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence and Types of Oral Complications Occuring in Hematological Malignancy Patients.:Cross Sectional Study
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Calculate the prevalence of oral complications. [Baseline]

      Calculate the prevalence of oral complications with special attention to infectious complications in hematological malignancy patients.

    Secondary Outcome Measures

    1. the morbidity related to oral complication in haematological malignancy patients. [Baseline]

      Study the morbidity related to oral complication in haematological malignancy patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Mai Mostafa, Assistant, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Merit Rafeek Gerges Botros, Assistant lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05758207
    Other Study ID Numbers:
    • Hematology malignancies
    First Posted:
    Mar 7, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Feb 1, 2023
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 7, 2023