The Management of RT-induced Hyposalivation Using LLLT

NCT ID: NCT05538169

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2023-10-01

Brief Summary

The primary purpose is to evaluate the effectiveness of photobiomodulation laser application in the management of patients with radiotherapy-induced hyposalivation. Secondary, to assess the changes in the scores of the patient's oral health-related quality of life using validated measurements.

Detailed Description

Head and neck cancer is a general term used to describe epithelial malignancies in the oral cavity, paranasal sinuses, nasal cavity, pharynx, and larynx. These malignancies are often presented as squamous cell carcinoma (SCC) of the head and neck with tobacco and alcohol consumption remaining the two main risk factors. In addition, human papillomavirus has been identified as another risk factor in a limited subset of these malignancies. More specifically, oral cancer accounts for 2%-4% of all cancer worldwide with 90% of these cases presented as SSC worldwide compared to 44.8% in Saudi Arabia. Clinically, patients often presented with white and/or red patches, hoarseness, non-healed ulcers, throat pain, and painless cervical lump which may persist for more than 3 weeks period.

Most head & neck cancer patients who received radiotherapy are likely to experience xerostomia and salivary glands hypofunction, mucositis, and possibly the loss of taste.

Furthermore, the effect of hyposalivation is not only limited to taste dysfunction but also associated with opportunistic infections, difficulty in chewing and speaking, rapid progression of caries, and oral mucositis. All these secondary complications are usually associated with pain and discomfort which will heavily affect the patient quality of life if they are untreated. Treatment options include moisturizing agents or artificial saliva which have a palliative effect however they are not preferred nor accepted by most patients.

The outcome of low-level laser therapy usage on cancer patients is well documented and well established in the literature. The vast majority of the results suggest that this therapy is an effective treatment option to stimulate salivary glands flow and decrease xerostomia/hyposalivation symptoms. In the present study, the efficiency of this treatment option will be tested as well as the changes in the patient's quality of life during and after the radiation treatment.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser therapy group

There will be 2 weekly applications of a low-level laser diode (Pioon Laser) for a 4-week active treatment period. Thus, a total of 8 therapeutic sessions will be conducted

Group Type: EXPERIMENTAL

low-level laser diode (Pioon Laser)

Intervention Type: DEVICE

Settings: the spot tip area of this tool is 0.088 cm2, semi-conductor diode, with a wavelength of 980 nm (near infrared), 200 mW output power, 1.97W/cm2 of power density, 3 J energy per point and application time 15 seconds per point].

• PBM will apply punctually, in continuous emissions.
• Extra-oral points: six points on each parotid gland, three points on each submandibular gland.
• Intra-oral points: two points on each sublingual gland.
• A total of 22 points will be applied in each session.

Interventions

low-level laser diode (Pioon Laser)

Settings: the spot tip area of this tool is 0.088 cm2, semi-conductor diode, with a wavelength of 980 nm (near infrared), 200 mW output power, 1.97W/cm2 of power density, 3 J energy per point and application time 15 seconds per point].

• PBM will apply punctually, in continuous emissions.
• Extra-oral points: six points on each parotid gland, three points on each submandibular gland.
• Intra-oral points: two points on each sublingual gland.
• A total of 22 points will be applied in each session.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 and above
• Clinically diagnosed with hyposalivation [an unstimulated salivary flow rate of ≤ 0.1ml per minute] (31) due to recent radiation therapy of SCC of the head and neck.

Exclusion Criteria

• Individuals with systemic diseases that could affect the salivary glands function such as (e.g. Sjogren syndrome) and medications (e.g. beta-blockers and diuretics for hypertension).
• Individuals who had an allergy to toluidine blue stain.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Abdullah Mohamed Alsoghier

Assistant Professor of Oral Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Saud Universiry

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

References

Alsoghier A, Mutaieb S, Bukhari A, AlQarni M, Alhazzaa S, Aljabab S, Alsuhaibani A, Faden A. Management of radiotherapy-induced hyposalivation using photobiomodulation therapy: a case series. Lasers Med Sci. 2025 Jan 20;40(1):25. doi: 10.1007/s10103-025-04292-3.

Reference Type: DERIVED

PMID: 39833441 (View on PubMed)

Other Identifiers

KingSaudU-E-21-6045

Identifier Type: -

Identifier Source: org_study_id