Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis

Phase 2

• Conditions: Oral Mucositis Due to Chemotherapy
• Interventions: Drug: Miconazole Topical Gel; Drug: chamomile topical oral gel; Drug: BBC oral spray; Drug: Oracure gel

• Registration Number: NCT04317183
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Study Timeline

• Study Start: 2019-05-15
• Status Verified: 2020-03
• Primary Completion: 2020-03-15
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Last Update Submitted: 2020-03-19
• Study First Posted: 2020-03-23
• Last Update Posted: 2020-03-23
• Study Completion: 2020-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional therapy	Miconazole Topical Gel	Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Dose: Three times a day for three weeks
conventional therapy	BBC oral spray	Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Dose: Three times a day for three weeks
conventional therapy	Oracure gel	Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Dose: Three times a day for three weeks
combination therapy	Miconazole Topical Gel	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
combination therapy	BBC oral spray	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
combination therapy	Oracure gel	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
Chamomile topical gel	chamomile topical oral gel	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).
combination therapy	chamomile topical oral gel	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine; 🇪🇬 Alexandria, Egypt