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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
diode laser with a wave length range of 800-980 n m and power less than 500 ml
Chamomile 3% mucoadhesive gel
Topical anti-inflammatory, topical analgesic and topical antifungal
Discomfort and pain
Reported by each patient using the Visual Analog Scale (0-10),10 refers to maximum pain
Time frame: On baseline, first, third, fifth, seventh, tenth and 14th day.
Oral mucositis severity
It will be measured using the WHO grading Scale (0-4).4 refers to ulcers, and diet is not possible (due to mucositis).
Time frame: On baseline, first, third, fifth, seventh, tenth and 14th day.
The total healing time of oral ulcers
will be recorded for all the patients
Time frame: On baseline, first, third, fifth, seventh, tenth and 14th day.
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