Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis

March 19, 2020 updated by: Hams Hamed Abdelrahman

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chamomile topical 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).
Drug: chamomile topical oral gel
Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.
Active Comparator: conventional therapy

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
topical anti fungal agent
Drug: BBC oral spray
Topical anesthetics and anti-inflammatory agent
Drug: Oracure gel
Topical analgesic gel
Experimental: combination therapy

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: Miconazole Topical Gel
topical anti fungal agent
Drug: BBC oral spray
Topical anesthetics and anti-inflammatory agent
Drug: Oracure gel
Topical analgesic gel
Drug: chamomile topical oral gel
Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Investigators

  • Study Director: Ehsan El-Negomy, PhD, Alexandria University
  • Study Director: Maha Talaab, PhD, Alexandria University
  • Study Director: Reham Ibrahim, Phd, Alexandria University
  • Study Director: Rasha El-Saka, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2019

Primary Completion (Actual)

March 15, 2020

Study Completion (Anticipated)

March 30, 2020

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00010556-IORG 0008839

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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