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Completed

NCT Number: NCT05034068

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

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.

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Key information

Conditions

Stomatitis (Oral Mucositis) Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of dental medicine Al-Azhar University (Assiut branch)

Asyut, Asyut Governorate, 71511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

0.15% bezaydamine hydrochloride.

Drug

0.15% bezaydamine hydrochloride was applied in oral mucosa in Patients with head and neck cancer under RT, CT treatment.

low power laser with a wavelength of 870 nm

Device

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

Primary outcomes

  1. TNF-α [picograms/millimeter (pg/ml)] in saliva

    Time frame: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)

    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.

  2. IL-6 [picograms/millimeter (pg/ml)] in saliva

    Time frame: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)

    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.

  3. WHO scale for severity of oral mucositis.

    Time frame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)

    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.

  4. National Institute of the Cancer-Common Toxicity criteria (NIC-CTC) RT-induced oral mucositis scale for extent of oral mucositis.

    Time frame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)

    (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

  5. visual analog scale (VAS) scale for pain assessment

    Time frame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)

    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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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