Low Level Laser Therapy Versus Benzydamin in Prevention and Treatment of Oral Mucositis

Low Level Laser Therapy Versus Benzydamin in Prevention and Treatment of Oral Mucositis Induced by Anticancer Treatments (Clinical and Biochemical Study)

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.

Study Overview

• Status: Completed
• Conditions: Stomatitis (Oral Mucositis)
• Intervention / Treatment: Drug: 0.15% bezaydamine hydrochloride.; Device: low power laser with a wavelength of 870 nm

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Asyut
    • Assiut, Asyut, Egypt, 71511
      • Faculty of dental medicine Al-Azhar University (Assiut branch)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; the patients will be treated by using oral care only and evaluation will be done before cancer treatment and weekly till the treatment completed. In each weekly visit, oral sites will be examined, and a score was given to each site based on the degree of mucositis.
Active Comparator: 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. In case of any problem (e.g. burning or stinging), patients will be allowed to dilute the solution with water in the ratio 1:1 or 1:2. Study evaluations will be conducted before cancer treatment and weekly thereafter until 2 weeks after completion of the therapy .In each weekly visit, oral sites were examined and a score was given to each site based on the degree of mucositis.	Drug: 0.15% bezaydamine hydrochloride.; 0.15% bezaydamine hydrochloride was applied in oral mucosa in Patients with head and neck cancer under RT, CT treatment.
Active Comparator: low-level laser therapy; 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. The power will be 60 mW, energy density of 6 J/cm2. Irradiation time will be 6 seconds per point based on the laser beam spot size of 0.55cm2. The irradiations will be done intra-orally avoiding the tumor site, oral examinations will be recorded at each irradiation session and the degree of mucositis will be recorded.	Device: low power laser with a wavelength of 870 nm; 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. The power will be 60 mW, energy density of 6 J/cm2. Irradiation time will be 6 seconds per point based on the laser beam spot size of 0.55cm2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNF-α [picograms/millimeter (pg/ml)] in saliva	Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80C. Enzyme-linked immunosorbent assays were used to quantify TNF-α amount in picograms.	Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)
IL-6 [picograms/millimeter (pg/ml)] in saliva	Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80C. Enzyme-linked immunosorbent assays were used to quantify IL-6 amount in picograms.	Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)
WHO scale for severity of oral mucositis.	WHO scale scoring severity of oral mucositis by assessor as following: Score 0-no signs or symptoms. Score 1-oral soreness and erythema. Score 2-oral erythema and ulcers, both solid and liquid diets tolerated. Score3-oral ulcers, liquid diet only. Score 4-oral alimentation impossible.	Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
National Institute of the Cancer-Common Toxicity criteria (NIC-CTC) RT-induced oral mucositis scale for extent of oral mucositis.	(NIC-CTC) RT-induced oral mucositis scale scoring extension of mucositid as following: (0) patients with oral mucosa presenting no visible alteration.; Presence of erythema.; Ulcers with up to 1.5 cm diameter and noncontiguous.; Ulcers larger than 1.5 cm diameter and contiguous.; Ulcers exhibiting necrosis and bleeding.; Death related to toxicity	Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
visual analog scale (VAS) scale for pain assessment	The VAS was modified according to the scale proposed by Bensadoun et al. : scores 1 and 2 (mild pain) were considered grade I, scores 3 and 4 (moderate pain) were grade II, scores of 5 to 7 (severe pain) were grade III and scores of 8 to 10 (very severe pain) were grade IV.	Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Ashraf I Gaafar, professor, Faculty of dental medicine Al-Azhar university Assiut Branch; Principal Investigator: Azza sh Mahmoud, phD, South Egypt Cancer Institute, Assiut University.

Publications and helpful links

General Publications

• Peterson DE. New strategies for management of oral mucositis in cancer patients. J Support Oncol. 2006 Feb;4(2 Suppl 1):9-13.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: Treatment of Oral Mucositis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No