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

NCT06214273 | Unknown Phase 2

• 1 other identifier: 27283522022441
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chemotherapy Induced Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (3)

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.

Drug: Ibuprofen analgesic and anti-inflammatory oral gel and miconazole 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.

Device: Low level diode laser

Chamomile

EXPERIMENTAL

The third group will receive chamomile 3% mucoadhesive gel.

Drug: Chamomile

Interventions

Low level diode laser DEVICE

diode laser with a wave length range of 800-980 n m and power less than 500 ml

Also known as: Photobiomodulation

low-level diode laser diode laser

Chamomile DRUG

Chamomile 3% mucoadhesive gel

Also known as: Matricaria

Chamomile

Ibuprofen analgesic and anti-inflammatory oral gel and miconazole anti fungal oral gel DRUG

Topical anti-inflammatory, topical analgesic and topical antifungal

Also known as: conventional oral therapy, Ibuprofen oral gel and miconazole oral gel

Ibuprofen oral gel and miconazole oral gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chemotherapy-induced oral mucositis.
• Patients who will agree to participate in the study.
• Adult Patients above 18 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (4)

• 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.

  PMID: 9145556 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.

  PMID: 32920135 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.

  PMID: 33290635 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.

  PMID: 32062592 RESULT

MeSH Terms

Interventions

Low-Level Light Therapy; Chamomile extract

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral medicine specialist

Model Details: 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.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 19, 2024
• Study Start: April 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share