Chemotherapy Induced Oral Mucositis
Conditions
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.
Interventions
DEVICELow level diode laser
diode laser with a wave length range of 800-980 n m and power less than 500 ml
DRUGChamomile
Chamomile 3% mucoadhesive gel
DRUGIbuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel
Topical anti-inflammatory, topical analgesic and topical antifungal
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, 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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed