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

Phase 2

Not yet recruiting

• Conditions: Chemotherapy Induced Oral Mucositis
• Interventions: Drug: Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel; Device: Low level diode laser; Drug: Chamomile

• Registration Number: NCT06214273
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-12-13
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-19
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Study Start: 2024-04
• Primary Completion: 2024-07
• Study Completion: 2024-10

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen oral gel and miconazole oral gel	Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal 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.
low-level diode laser diode laser	Low level 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.
Chamomile	Chamomile	The third group will receive chamomile 3% mucoadhesive gel.

Primary Outcome Measures

Name	Time	Method
Discomfort and pain	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

Secondary Outcome Measures

Name	Time	Method
Oral mucositis severity	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).
The total healing time of oral ulcers	On baseline, first, third, fifth, seventh, tenth and 14th day.	will be recorded for all the patients