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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen oral gel and miconazole oral gel | Active Comparator | 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 | Experimental | The second group will receive a diode laser with a wave length range of 800-980 nm and power less than 500 ml. |
|
| Chamomile | Experimental | The third group will receive chamomile 3% mucoadhesive gel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low level diode laser | Device | diode laser with a wave length range of 800-980 n m and power less than 500 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort and pain | Reported by each patient using the Visual Analog Scale (0-10),10 refers to maximum pain | On baseline, first, third, fifth, seventh, tenth and 14th day. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | On baseline, first, third, fifth, seventh, tenth and 14th day. |
| The total healing time of oral ulcers |
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Inclusion criteria:
Exclusion criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9145556 | Result | Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer Nurs. 1997 Apr;20(2):88-93. doi: 10.1097/00002820-199704000-00002. | |
| 32920135 | Result | Soares ADS, Wanzeler AMV, Cavalcante GHS, Barros EMDS, Carneiro RCM, Tuji FM. Therapeutic effects of andiroba (Carapa guianensis Aubl) oil, compared to low power laser, on oral mucositis in children underwent chemotherapy: A clinical study. J Ethnopharmacol. 2021 Jan 10;264:113365. doi: 10.1016/j.jep.2020.113365. Epub 2020 Sep 10. |
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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.
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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.
| Chamomile | Drug | Chamomile 3% mucoadhesive gel |
|
|
| Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel | Drug | Topical anti-inflammatory, topical analgesic and topical antifungal |
|
|
will be recorded for all the patients
| On baseline, first, third, fifth, seventh, tenth and 14th day. |
| 33290635 | Result | Elhadad MA, El-Negoumy E, Taalab MR, Ibrahim RS, Elsaka RO. The effect of topical chamomile in the prevention of chemotherapy-induced oral mucositis: A randomized clinical trial. Oral Dis. 2022 Jan;28(1):164-172. doi: 10.1111/odi.13749. Epub 2020 Dec 19. |
| 32062592 | Result | de Lima VHS, de Oliveira-Neto OB, da Hora Sales PH, da Silva Torres T, de Lima FJC. Effectiveness of low-level laser therapy for oral mucositis prevention in patients undergoing chemoradiotherapy for the treatment of head and neck cancer: A systematic review and meta-analysis. Oral Oncol. 2020 Mar;102:104524. doi: 10.1016/j.oraloncology.2019.104524. Epub 2020 Feb 13. |
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| C000713170 | Chamomile extract |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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