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

Cairo University (CU)

Status and phase

Not yet enrolling

Phase 2

Conditions

Chemotherapy Induced Oral Mucositis

Treatments

Drug: Chamomile

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

Device: Low level diode laser

Study type

Interventional

Funder types

Other

Identifiers

NCT06214273

27283522022441

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 3 patient groups

Ibuprofen oral gel and miconazole oral gel

Active Comparator group

Description:

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.

Treatment:

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

low-level diode laser diode laser

Experimental group

Description:

The second group will receive a diode laser with a wave length range of 800-980 nm and power less than 500 ml.

Treatment:

Device: Low level diode laser

Chamomile

Experimental group

Description:

The third group will receive chamomile 3% mucoadhesive gel.