Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Topical Chamomile in the Prevention of Chemotherapy-induced Oral Mucositis (a Randomized Controlled Clinical Trial)

Conditions
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Oral Mucositis Due to Chemotherapy

Intervention / Treatment
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* Drug: chamomile topical oral gel
* Drug: Miconazole Topical Gel
* Drug: BBC oral spray
* Drug: Oracure gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chamomile topical gel<br>Topical oral chamomile gel three times daily for three weeks. Topical oral chamomile gel is prepared with the aid of Pharmacognosy and pharmaceutics departments, faculty of pharmacy, Alexandria University and mucoadhesive hydrogels (Carbopol® 970). | Drug: chamomile topical oral gel<br>* Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.<br>|
| Active Comparator: conventional therapy<br>Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Dose: Three times a day for three weeks | Drug: Miconazole Topical Gel<br>* topical anti fungal agent<br>Drug: BBC oral spray<br>* Topical anesthetics and anti-inflammatory agent<br>Drug: Oracure gel<br>* Topical analgesic gel<br>|
| Experimental: combination therapy<br>Topical oral chamomile gel three times daily for three weeks in combination with the symptomatic treatment Symptomatic treatment which included: Miconaz oral gel BBC oral spray Oracure gel Symptomatic treatment dose: Three times a day for three weeks | Drug: chamomile topical oral gel<br>* Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.<br>Drug: Miconazole Topical Gel<br>* topical anti fungal agent<br>Drug: BBC oral spray<br>* Topical anesthetics and anti-inflammatory agent<br>Drug: Oracure gel<br>* Topical analgesic gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in severity of oral mucositis at different time points along the study | 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. | Up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and discomfort severity at different time points along the study: Numeric Rating Scale | 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. | Up to 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral mucositis, chemotherapy, chamomile.