Clinical trial NCT05034068: Low Level Laser Therapy Versus Benzydamin in Prevention and Treatment of Oral Mucositis
Official title: Low Level Laser Therapy Versus Benzydamin in Prevention and Treatment of Oral Mucositis Induced by Anticancer Treatments (Clinical and Biochemical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stomatitis (Oral Mucositis)
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective study will be conducted at the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology Faculty of Dental Medicine, Assiut branch Al-Azhar University. Patients with head and neck cancer under RT, CT treatment participated in this study were selected from South Egypt Cancer Institute. During clinical examination the medical history of the patient will be recorded. Data related to base illness, type and stage of RT treatment, association or not to chemotherapy will be collected during the whole treatment. After clinical examination, the patients will receive a kit containing toothbrush, dentifrice, and subsequent oral hygiene instruction. Then the patients will be classified into 3 groups as follow: Group I (control group): the patients will be treated by using oral care only and evaluation will be done before cancer treatment and weekly till the treatment completed. Group II: the patients will be treated by using 0.15% bezaydamine hydrochloride. All patients were advised to rinse 15 mL of the solution benzydamine for 2 min, four to eight times daily before and during, and for 2 weeks after completion of cancer therapy. Group III: the patients will be treated by using a low-level laser therapy, the irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa.


Eligibility criteria: Inclusion Criteria:

-patients with head and neck carcinoma were scheduled to receive a RT treatment (two dimensional techniques), covering a wide area of the head and neck region, The RT protocol of the hospital for head and neck cancer patients consisted of treatment sessions 5 days a week, 2Gy per fraction, with a total dose of 70 Gy over 7 weeks (35 sessions). A minimum dose of 50 Gy was delivered to the oral cavity of all patients in the study, either exclusively or associated with chemotherapy.

Exclusion Criteria:

* Karnofsky performance status (KPS)less than 60% .
* Hypersensitivity to benzydamine or typical NSAIDs.
* Patients were excluded if they had lock jaw, any previous medical condition (s) hampering wound healing (e.g., diabetes mellitus).

Primary outcomes:
measure: TNF-α [picograms/millimeter (pg/ml)] in saliva
timeFrame: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)
measure: IL-6 [picograms/millimeter (pg/ml)] in saliva
timeFrame: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)
measure: WHO scale for severity of oral mucositis.
timeFrame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
measure: National Institute of the Cancer-Common Toxicity criteria (NIC-CTC) RT-induced oral mucositis scale for extent of oral mucositis.
timeFrame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
measure: visual analog scale (VAS) scale for pain assessment
timeFrame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of dental medicine Al-Azhar University (Assiut branch)
state: Asyut
Study officials:
affiliation: Faculty of dental medicine Al-Azhar university Assiut Branch
name: Ashraf I Gaafar, professor
role: STUDY_DIRECTOR
affiliation: South Egypt Cancer Institute, Assiut University.
name: Azza sh Mahmoud, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.
citation: Peterson DE. New strategies for management of oral mucositis in cancer patients. J Support Oncol. 2006 Feb;4(2 Suppl 1):9-13.
citation: Guimaraes DM, Ota TMN, Da Silva DAC, Almeida FLDS, Schalch TD, Deana AM, Junior JMA, Fernandes KPS. Low-level laser or LED photobiomodulation on oral mucositis in pediatric patients under high doses of methotrexate: prospective, randomized, controlled trial. Support Care Cancer. 2021 Nov;29(11):6441-6447. doi: 10.1007/s00520-021-06206-9. Epub 2021 Apr 24.