Clinical trial NCT06214273: Low Level Diode Laser Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis
Official title: Evaluation of Low Level Diode Diode Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis: Three Arm Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chemotherapy Induced Oral Mucositis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Discomfort and pain
timeFrame: On baseline, first, third, fifth, seventh, tenth and 14th day.
Secondary outcomes:
measure: Oral mucositis severity
timeFrame: On baseline, first, third, fifth, seventh, tenth and 14th day.
measure: The total healing time of oral ulcers
timeFrame: On baseline, first, third, fifth, seventh, tenth and 14th day.
Other outcomes:
Locations:
Study officials:
References:
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.
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 Ethnopharmacol. 2021 Jan 10;264:113365. doi: 10.1016/j.jep.2020.113365. Epub 2020 Sep 10.
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.
citation: 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.