Evaluation of Low Level Diode Diode Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis: Three Arm Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 45
- Primary Endpoint
- Discomfort and pain
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel (Drug)
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.
Intervention: Low level diode laser (Device)
Chamomile
The third group will receive chamomile 3% mucoadhesive gel.
Intervention: Chamomile (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Oral mucositis severity(On baseline, first, third, fifth, seventh, tenth and 14th day.)
- The total healing time of oral ulcers(On baseline, first, third, fifth, seventh, tenth and 14th day.)
Investigators
Clair Sobhy Nagieb Botros
Oral medicine specialist
Cairo University