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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chemotherapy Induced Oral Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a three-arm head-to-head RCT assessing two of the promising studied interventions, low-level diode laser and topical chamomile, comparing them to each other's and to conventional therapy.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Double-blinded trial:

The outcome assessor and the statistician will be blinded. Participants can't be blinded because of the difference in intervention methods of application.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel

Intervention Type DRUG

Topical anti-inflammatory, topical analgesic and topical antifungal

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.

Group Type EXPERIMENTAL

Low level diode laser

Intervention Type DEVICE

diode laser with a wave length range of 800-980 n m and power less than 500 ml

Chamomile

The third group will receive chamomile 3% mucoadhesive gel.

Group Type EXPERIMENTAL

Chamomile

Intervention Type DRUG

Chamomile 3% mucoadhesive gel

Interventions

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Low level diode laser

diode laser with a wave length range of 800-980 n m and power less than 500 ml

Intervention Type DEVICE

Chamomile

Chamomile 3% mucoadhesive gel

Intervention Type DRUG

Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel

Topical anti-inflammatory, topical analgesic and topical antifungal

Intervention Type DRUG

Other Intervention Names

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Photobiomodulation Matricaria conventional oral therapy Ibuprofen oral gel and miconazole oral gel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No