Low Level Diode Laser Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis

January 22, 2024 updated by: Clair Sobhy Nagieb Botros, Cairo University

Evaluation of Low Level Diode Diode Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis: Three Arm Randomized Clinical Trial

a three-arm head-to-head randomized clinical trial assessing two of the promising studied interventions, low-level diode laser and topical Chamomile, comparing them to each other's and to conventional therapy in the management of oral mucositis-induced chemotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The latest MASCC/ISOO Mucositis Guidelines recommend relieving pain, reducing inflammation, and preventing secondary infection as the main pillars in the management of chemotherapy-induced oral mucositis. Accordingly, our comparator will be conventional therapy, including topical anti-inflammatory, topical analgesic, and topical antifungal.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patients with chemotherapy-induced oral mucositis.
  • Patients who will agree to participate in the study.
  • Adult Patients above 18 years.

Exclusion criteria:

  • Patients with any visible oral lesions other than oral mucositis.
  • Patients who have received radiotherapy 2 weeks earlier to the diagnosis of the oral mucositis

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ibuprofen oral gel and miconazole oral gel
One group will receive conventional oral therapy composed of topical ibuprofen oral gel as an anti-inflammatory and analgesic and topical miconazole as an anti-fungal oral gel.
Drug: Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel
Topical anti-inflammatory, topical analgesic and topical antifungal
Other Names:
  • conventional oral therapy
  • Ibuprofen oral gel and miconazole oral gel
Experimental: low-level diode laser diode laser
The second group will receive a diode laser with a wave length range of 800-980 nm and power less than 500 ml.
Device: Low level diode laser
diode laser with a wave length range of 800-980 n m and power less than 500 ml
Other Names:
  • Photobiomodulation
Experimental: Chamomile
The third group will receive chamomile 3% mucoadhesive gel.
Drug: Chamomile
Chamomile 3% mucoadhesive gel
Other Names:
  • Matricaria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discomfort and pain
Time Frame: On baseline, first, third, fifth, seventh, tenth and 14th day.
Reported by each patient using the Visual Analog Scale (0-10),10 refers to maximum pain
On baseline, first, third, fifth, seventh, tenth and 14th day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral mucositis severity
Time Frame: On baseline, first, third, fifth, seventh, tenth and 14th day.
It will be measured using the WHO grading Scale (0-4).4 refers to ulcers, and diet is not possible (due to mucositis).
On baseline, first, third, fifth, seventh, tenth and 14th day.
The total healing time of oral ulcers
Time Frame: On baseline, first, third, fifth, seventh, tenth and 14th day.
will be recorded for all the patients
On baseline, first, third, fifth, seventh, tenth and 14th day.

Collaborators and Investigators

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

Sponsor

Cairo 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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 19, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27283522022441

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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