Oral Mucositis Due to Chemotherapy
Conditions
Keywords
oral mucositis, chemotherapy, chamomile.
Brief summary
the main aim of this study is to clinically assess the effectiveness of topical chamomile oral gel in the prevention of chemotherapy-induced oral mucositis.
Detailed description
The study was designed as a randomized, controlled, clinical trial. patients who were undergoing to receive chemotherapy were divided into three groups: Group I: was given conventional treatment. Group II: was given topical oral gel of chamomile. Group III: was given topical oral gel of chamomile in combination with the conventional treatment. All patients have clinically evaluated at the start of the chemotherapy and three weeks later for pain and oral mucositis severity.
Interventions
DRUGchamomile topical oral gel
Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.
topical anti fungal agent
DRUGBBC oral spray
Topical anesthetics and anti-inflammatory agent
DRUGOracure gel
Topical analgesic gel
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are going to receive 5-Fluoroucil (5-FU) based chemotherapy regime. Males and females with an age of not less than 20 years and not exceeding 70 years.
Exclusion criteria
* 1\. Patients suffering from any uncontrolled systemic diseases that affect integrity of the epithelium (such as diabetes, cardiovascular, liver disorder and renal dysfunction) 2. Pregnant and lactating women 3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in severity of oral mucositis at different time points along the study | Up to 3 weeks | Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third week after the first chemotherapy session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain and discomfort severity at different time points along the study: Numeric Rating Scale | Up to 3 weeks | Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the first , second and third week after the chemotherapy session. |
Countries
Egypt
Contacts
Primary ContactMahmoud Elhadad, BDS
Outcome results
None listed