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

Chemotherapy Induced Oral Mucositis Clinical Trial

Official title:

Evaluation of Low Level Diode Diode Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis: Three Arm Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06214273
• Other study ID #: 27283522022441
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Induced Oral Mucositis
• Mucositis
• Stomatitis

Intervention

Device:
• Low level diode laser
diode laser with a wave length range of 800-980 n m and power less than 500 ml

Drug:
• Chamomile
Chamomile 3% mucoadhesive gel
• Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel
Topical anti-inflammatory, topical analgesic and topical antifungal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (4)

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 rev — View Citation

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. — View Citation

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. — View Citation

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 Ethnopharmac — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	The total healing time of oral ulcers	will be recorded for all the patients	On baseline, first, third, fifth, seventh, tenth and 14th day.