Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis

Hams Hamed Abdelrahman

Status and phase: Unknown; Phase 2

Conditions: Oral Mucositis Due to Chemotherapy

Treatments: Drug: BBC oral spray; Drug: Oracure gel; Drug: chamomile topical oral gel; Drug: Miconazole Topical Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04317183

00010556-IORG 0008839

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Chamomile topical gel

Experimental group

Description:

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).

Treatment:

Drug: chamomile topical oral gel

conventional therapy

Active Comparator group

Description:

Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Dose: Three times a day for three weeks

Treatment:

Drug: BBC oral spray

Drug: Miconazole Topical Gel

Drug: Oracure gel

combination therapy

Experimental group

Description:

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

Treatment:

Drug: BBC oral spray

Drug: Miconazole Topical Gel

Drug: Oracure gel

Drug: chamomile topical oral gel