The Management of RT-induced Hyposalivation Using LLLT

Head and Neck Cancer Clinical Trial

— REACH-LLLT  

Official title:

The Management of Radiotherapy-induced Hyposalivation Using Low-level Laser Therapy: A Case Series.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05538169
• Other study ID #: KingSaudU-E-21-6045
• Status: Completed
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Xerostomia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Saudi Arabia	King Saud Universiry	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unstimulated and stimulated salivary flow rate	The unstimulated and stimulated salivary flow rate (ml/minute) will be collected at three different time periods: (T1) the first visit and before applying the laser, (T2) the 8th visit and after using the laser, and (T3) the re-evaluation visit after two months.	12 weeks
Secondary	Xerostomia assessment	Xerostomia will be analysed at (T1) first visit, (T2) 8th visit, and (T3) at the re-evaluation visit using the Arabic version of Xerostomia Inventory, which is assessed by a 4-point scale (from never = 0 to always = 3).	12 weeks
Secondary	Dysgeusia assessment	Dysgeusia will be analysed at (T1) first visit, (T2) 8th visit, and (T3) at the re-evaluation visit using the 11-item Dysguesia Questionnaire, which is assessed by a mix of choices (e.g. yes or no) and 4-point scale for each question (little, tolerably, a lot or don't rememeber).	12 weeks
Secondary	Quality of life assessment	The Oral health-related quality of life (OHQoL) will be measured at (T1) first visit, (T2) 8th visit, and (T3) at the re-evaluation visit using the validated Arabic version of Oral Health Impact Profile (OHIP-5), which is which is assessed by a 5-point scale (from never = 0 to always = 4).	12 weeks